Trial Outcomes & Findings for Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS (NCT NCT00574548)
NCT ID: NCT00574548
Last Updated: 2011-07-22
Results Overview
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
720 participants
Primary outcome timeframe
1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Results posted on
2011-07-22
Participant Flow
Participant milestones
| Measure |
13vPnC - Group 1.1 or 1.2
Group 1.1: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
|
23vPS - Group 2
Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
|---|---|---|
|
Overall Study
STARTED
|
482
|
238
|
|
Overall Study
Received Vaccination 1 (Vax 1)
|
478
|
237
|
|
Overall Study
Completed Vax 1 (6 Month Contact)
|
468
|
234
|
|
Overall Study
Withdrawn After Vax 1 (6 Month Contact)
|
7
|
3
|
|
Overall Study
Withdrawn Before Vax 2
|
41
|
11
|
|
Overall Study
Received Vax 2
|
427
|
223
|
|
Overall Study
Completed Vax 2 (6 Month Contact)
|
421
|
222
|
|
Overall Study
COMPLETED
|
421
|
222
|
|
Overall Study
NOT COMPLETED
|
61
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS
Baseline characteristics by cohort
| Measure |
13vPnC - Group 1.1 or 1.2
n=478 Participants
Group 1.1: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
|
23vPS - Group 2
n=237 Participants
Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
Total
n=715 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
61.7 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
61.7 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
281 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
415 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
197 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)Population: Evaluable immunogenicity population: participants who were eligible for the study, adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations. GMTs were calculated using all participants with available data for the specified blood draw.
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Outcome measures
| Measure |
13vPnC / 23vPS
n=233 Participants
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
|
23vPS
n=229 Participants
23vPS administered as a single dose 0.5 mL IM at Year 0.
|
23vPS / 13vPnC
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
|---|---|---|---|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)
Common Serotype 1
|
148 geometric mean titer
Interval 123.7 to 176.5
|
148 geometric mean titer
Interval 117.9 to 185.9
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)
Common Serotype 3
|
125 geometric mean titer
Interval 108.6 to 143.4
|
80 geometric mean titer
Interval 67.5 to 95.7
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)
Common Serotype 4
|
1385 geometric mean titer
Interval 1171.2 to 1638.7
|
1357 geometric mean titer
Interval 1023.0 to 1799.0
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)
Common Serotype 5
|
199 geometric mean titer
Interval 161.4 to 246.2
|
140 geometric mean titer
Interval 107.0 to 183.5
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)
Common Serotype 6B
|
1215 geometric mean titer
Interval 965.4 to 1528.3
|
706 geometric mean titer
Interval 522.1 to 954.0
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)
Common Serotype 7F
|
537 geometric mean titer
Interval 422.4 to 682.6
|
331 geometric mean titer
Interval 233.5 to 469.1
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)
Common Serotype 9V
|
373 geometric mean titer
Interval 268.4 to 517.6
|
288 geometric mean titer
Interval 198.0 to 419.1
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)
Common Serotype 14
|
622 geometric mean titer
Interval 485.7 to 796.4
|
734 geometric mean titer
Interval 543.6 to 990.1
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)
Common Serotype 18C
|
1062 geometric mean titer
Interval 863.2 to 1307.6
|
789 geometric mean titer
Interval 586.2 to 1062.2
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)
Common Serotype 19A
|
467 geometric mean titer
Interval 403.5 to 541.0
|
376 geometric mean titer
Interval 302.8 to 465.7
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)
Common Serotype 19F
|
774 geometric mean titer
Interval 642.0 to 933.6
|
509 geometric mean titer
Interval 385.5 to 672.9
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)
Common Serotype 23F
|
198 geometric mean titer
Interval 151.2 to 259.4
|
70 geometric mean titer
Interval 49.9 to 97.3
|
—
|
PRIMARY outcome
Timeframe: 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)Population: Evaluable immunogenicity population. GMTs were calculated using all participants with available data for the specified blood draw.
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Outcome measures
| Measure |
13vPnC / 23vPS
n=233 Participants
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
|
23vPS
n=196 Participants
23vPS administered as a single dose 0.5 mL IM at Year 0.
|
23vPS / 13vPnC
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
|---|---|---|---|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)
Common Serotype 1
|
148 geometric mean titer
Interval 123.7 to 176.5
|
77 geometric mean titer
Interval 60.7 to 98.1
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)
Common Serotype 3
|
125 geometric mean titer
Interval 108.6 to 143.4
|
50 geometric mean titer
Interval 40.9 to 61.7
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)
Common Serotype 4
|
1385 geometric mean titer
Interval 1171.2 to 1638.7
|
935 geometric mean titer
Interval 739.9 to 1182.4
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)
Common Serotype 5
|
199 geometric mean titer
Interval 161.4 to 246.2
|
85 geometric mean titer
Interval 64.2 to 112.0
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)
Common Serotype 6B
|
1215 geometric mean titer
Interval 965.4 to 1528.3
|
710 geometric mean titer
Interval 529.1 to 953.2
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)
Common Serotype 7F
|
537 geometric mean titer
Interval 422.4 to 682.6
|
126 geometric mean titer
Interval 85.6 to 184.6
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)
Common Serotype 9V
|
373 geometric mean titer
Interval 268.4 to 517.6
|
114 geometric mean titer
Interval 76.5 to 169.3
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)
Common Serotype 14
|
622 geometric mean titer
Interval 485.7 to 796.4
|
435 geometric mean titer
Interval 323.0 to 585.7
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)
Common Serotype 18C
|
1062 geometric mean titer
Interval 863.2 to 1307.6
|
564 geometric mean titer
Interval 418.2 to 761.7
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)
Common Serotype 19A
|
467 geometric mean titer
Interval 403.5 to 541.0
|
289 geometric mean titer
Interval 235.7 to 353.9
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)
Common Serotype 19F
|
774 geometric mean titer
Interval 642.0 to 933.6
|
286 geometric mean titer
Interval 217.3 to 376.7
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)
Common Serotype 23F
|
198 geometric mean titer
Interval 151.2 to 259.4
|
124 geometric mean titer
Interval 88.2 to 173.0
|
—
|
SECONDARY outcome
Timeframe: 1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)Population: Evaluable immunogenicity population. GMTs were calculated using all participants with available data who had determinate assay values at both the postvaccination 1 (13vPnC; Year 0) and postvaccination 2 (13vPnC / 13vPnC; Year 1) time points.
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for the pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The 6A pneumococcal serotype is specific to 13vPnC. Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Outcome measures
| Measure |
13vPnC / 23vPS
n=127 Participants
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
|
23vPS
n=127 Participants
23vPS administered as a single dose 0.5 mL IM at Year 0.
|
23vPS / 13vPnC
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
|---|---|---|---|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 1
|
215 geometric mean titer
Interval 163.9 to 282.4
|
142 geometric mean titer
Interval 112.2 to 180.4
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 3
|
73 geometric mean titer
Interval 57.2 to 94.1
|
89 geometric mean titer
Interval 75.2 to 105.4
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 4
|
2255 geometric mean titer
Interval 1625.2 to 3128.6
|
1214 geometric mean titer
Interval 931.8 to 1582.1
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 5
|
170 geometric mean titer
Interval 112.1 to 258.6
|
98 geometric mean titer
Interval 69.6 to 136.6
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Additional Serotype 6A
|
2682 geometric mean titer
Interval 1969.5 to 3652.1
|
2281 geometric mean titer
Interval 1747.1 to 2978.5
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 6B
|
2112 geometric mean titer
Interval 1508.0 to 2958.2
|
1882 geometric mean titer
Interval 1429.7 to 2477.9
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 7F
|
930 geometric mean titer
Interval 602.1 to 1437.1
|
323 geometric mean titer
Interval 215.8 to 482.8
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 9V
|
919 geometric mean titer
Interval 619.1 to 1364.0
|
335 geometric mean titer
Interval 214.6 to 522.6
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 14
|
492 geometric mean titer
Interval 312.7 to 774.5
|
384 geometric mean titer
Interval 262.4 to 561.2
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 18C
|
1440 geometric mean titer
Interval 1015.3 to 2043.5
|
986 geometric mean titer
Interval 730.8 to 1330.2
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 19A
|
583 geometric mean titer
Interval 426.6 to 796.8
|
385 geometric mean titer
Interval 308.2 to 481.6
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 19F
|
566 geometric mean titer
Interval 385.7 to 829.2
|
502 geometric mean titer
Interval 381.3 to 662.1
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 23F
|
291 geometric mean titer
Interval 187.7 to 452.2
|
456 geometric mean titer
Interval 322.4 to 644.7
|
—
|
SECONDARY outcome
Timeframe: 1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)Population: Evaluable immunogenicity population. GMTs were calculated using all participants with available data who had determinate assay values at both the postvaccination 1 (13vPnC; Year 0) and postvaccination 2 (13vPnC / 23vPS; Year 1) time points.
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Outcome measures
| Measure |
13vPnC / 23vPS
n=221 Participants
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
|
23vPS
n=221 Participants
23vPS administered as a single dose 0.5 mL IM at Year 0.
|
23vPS / 13vPnC
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
|---|---|---|---|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)
Common Serotype 1
|
220 geometric mean titer
Interval 178.9 to 269.3
|
140 geometric mean titer
Interval 117.4 to 168.1
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)
Common Serotype 3
|
74 geometric mean titer
Interval 61.3 to 88.7
|
129 geometric mean titer
Interval 112.4 to 147.5
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)
Common Serotype 4
|
2517 geometric mean titer
Interval 2091.7 to 3029.2
|
1430 geometric mean titer
Interval 1214.7 to 1683.9
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)
Common Serotype 5
|
227 geometric mean titer
Interval 170.9 to 300.5
|
188 geometric mean titer
Interval 151.1 to 234.8
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)
Common Serotype 6B
|
2012 geometric mean titer
Interval 1571.9 to 2574.1
|
1351 geometric mean titer
Interval 1087.6 to 1677.0
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)
Common Serotype 7F
|
1252 geometric mean titer
Interval 971.1 to 1614.4
|
533 geometric mean titer
Interval 419.2 to 678.2
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)
Common Serotype 9V
|
758 geometric mean titer
Interval 563.8 to 1018.9
|
406 geometric mean titer
Interval 292.3 to 564.6
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)
Common Serotype 14
|
664 geometric mean titer
Interval 485.1 to 908.5
|
616 geometric mean titer
Interval 473.3 to 802.2
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)
Common Serotype 18C
|
1532 geometric mean titer
Interval 1183.7 to 1982.7
|
1074 geometric mean titer
Interval 871.7 to 1322.2
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)
Common Serotype 19A
|
696 geometric mean titer
Interval 581.1 to 833.6
|
457 geometric mean titer
Interval 389.5 to 536.3
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)
Common Serotype 19F
|
696 geometric mean titer
Interval 546.3 to 887.7
|
773 geometric mean titer
Interval 636.6 to 937.6
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)
Common Serotype 23F
|
358 geometric mean titer
Interval 265.5 to 481.7
|
216 geometric mean titer
Interval 165.0 to 282.7
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)Population: Evaluable immunogenicity population. GMTs were calculated using all participants with available data for the specified blood draw.
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Outcome measures
| Measure |
13vPnC / 23vPS
n=455 Participants
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
|
23vPS
n=196 Participants
23vPS administered as a single dose 0.5 mL IM at Year 0.
|
23vPS / 13vPnC
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
|---|---|---|---|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 1
|
207 geometric mean titer
Interval 177.7 to 240.9
|
77 geometric mean titer
Interval 60.7 to 98.1
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 3
|
75 geometric mean titer
Interval 66.0 to 85.3
|
50 geometric mean titer
Interval 40.9 to 61.7
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 4
|
2536 geometric mean titer
Interval 2192.3 to 2933.0
|
935 geometric mean titer
Interval 739.9 to 1182.4
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 5
|
215 geometric mean titer
Interval 175.9 to 261.7
|
85 geometric mean titer
Interval 64.2 to 112.0
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 6B
|
1948 geometric mean titer
Interval 1614.0 to 2351.7
|
710 geometric mean titer
Interval 529.1 to 953.2
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 7F
|
1063 geometric mean titer
Interval 868.6 to 1302.2
|
126 geometric mean titer
Interval 85.6 to 184.6
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 9V
|
767 geometric mean titer
Interval 620.0 to 949.3
|
114 geometric mean titer
Interval 76.5 to 169.3
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 14
|
650 geometric mean titer
Interval 524.9 to 805.8
|
435 geometric mean titer
Interval 323.0 to 585.7
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 18C
|
1576 geometric mean titer
Interval 1321.3 to 1880.9
|
564 geometric mean titer
Interval 418.2 to 761.7
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 19A
|
709 geometric mean titer
Interval 618.9 to 811.2
|
289 geometric mean titer
Interval 235.7 to 353.9
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 19F
|
711 geometric mean titer
Interval 595.9 to 848.9
|
286 geometric mean titer
Interval 217.3 to 376.7
|
—
|
|
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 23vPS / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Common Serotype 23F
|
354 geometric mean titer
Interval 283.8 to 440.7
|
124 geometric mean titer
Interval 88.2 to 173.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)Population: Safety population includes all participants who receive at least 1 dose of study vaccine. N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 23vPS, respectively. Participants may be represented in more than 1 category.
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \[cm\]; Moderate (5.1 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Outcome measures
| Measure |
13vPnC / 23vPS
n=374 Participants
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
|
23vPS
n=180 Participants
23vPS administered as a single dose 0.5 mL IM at Year 0.
|
23vPS / 13vPnC
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Redness: Any (n=270, 134)
|
12.2 percentage of participants
|
11.2 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Redness: Mild (n=266, 134)
|
8.3 percentage of participants
|
9.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Redness: Moderate (n=264, 128)
|
6.4 percentage of participants
|
3.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Redness: Severe (n=259, 127)
|
1.2 percentage of participants
|
0.8 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Swelling: Any (n=270, 135)
|
10.0 percentage of participants
|
10.4 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Swelling: Mild (n=268, 132)
|
8.2 percentage of participants
|
6.1 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Swelling: Moderate (n=263, 132)
|
3.8 percentage of participants
|
7.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Swelling: Severe (n=258, 127)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Pain: Any (n=370, 175)
|
69.2 percentage of participants
|
58.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Pain: Mild (n=360, 170)
|
66.1 percentage of participants
|
52.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Pain: Moderate (n=284, 143)
|
20.1 percentage of participants
|
21.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Pain: Severe (n=261, 127)
|
2.3 percentage of participants
|
0.8 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Limitation of arm movement: Any (n=289, 142)
|
23.5 percentage of participants
|
28.2 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Limitation of arm movement: Mild (n=286, 142)
|
22.7 percentage of participants
|
26.1 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Limitation of arm movement: Moderate (n=260, 127)
|
1.2 percentage of participants
|
3.1 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Limitation of arm movement: Severe (n=261, 128)
|
1.1 percentage of participants
|
2.3 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)Population: Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 13vPnC / 13vPnC, respectively. Participants may be represented in more than 1 category.
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \[cm\]; Moderate (5.1 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Outcome measures
| Measure |
13vPnC / 23vPS
n=110 Participants
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
|
23vPS
n=110 Participants
23vPS administered as a single dose 0.5 mL IM at Year 0.
|
23vPS / 13vPnC
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Limitation of arm movement: Severe (n=56, 56)
|
0.0 percentage of participants
|
1.8 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Redness: Any (n=61, 61)
|
14.8 percentage of participants
|
11.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Redness: Mild (n=57, 57)
|
7.0 percentage of participants
|
8.8 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Redness: Moderate (n=58, 58)
|
8.6 percentage of participants
|
3.4 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Redness: Severe (n=57, 57)
|
0.0 percentage of participants
|
3.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Swelling: Any (n=60, 60)
|
10.0 percentage of participants
|
11.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Swelling: Mild (n=59, 59)
|
6.8 percentage of participants
|
8.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Swelling: Moderate (n=55, 55)
|
1.8 percentage of participants
|
3.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Swelling: Severe (n=56, 56)
|
0.0 percentage of participants
|
1.8 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Pain: Any (n=108, 108)
|
76.9 percentage of participants
|
75.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Pain: Mild (n=101, 101)
|
72.3 percentage of participants
|
72.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Pain: Moderate (n=61, 61)
|
21.3 percentage of participants
|
26.2 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Pain: Severe (n=57, 57)
|
0.0 percentage of participants
|
3.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Limitation of arm movement: Any (n=65, 65)
|
26.2 percentage of participants
|
24.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Limitation of arm movement: Mild (n=65, 65)
|
26.2 percentage of participants
|
24.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Limitation of arm movement: Moderate (n=56, 56)
|
1.8 percentage of participants
|
0.0 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)Population: Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \[cm\]; Moderate (5.1 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Outcome measures
| Measure |
13vPnC / 23vPS
n=374 Participants
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
|
23vPS
n=171 Participants
23vPS administered as a single dose 0.5 mL IM at Year 0.
|
23vPS / 13vPnC
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Redness: Any (n=270, 115)
|
12.2 percentage of participants
|
4.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Redness: Mild (n=266, 115)
|
8.3 percentage of participants
|
4.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Redness: Moderate (n=264, 115)
|
6.4 percentage of participants
|
0.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Redness: Severe (n=259, 115)
|
1.2 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Swelling: Any (n=270, 119)
|
10.0 percentage of participants
|
5.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Swelling: Mild (n=268, 119)
|
8.2 percentage of participants
|
5.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Swelling: Moderate (n=263, 116)
|
3.8 percentage of participants
|
0.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Swelling: Severe (n=258, 115)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Pain: Any (n=370, 169)
|
69.2 percentage of participants
|
69.8 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Pain: Mild (n=360, 166)
|
66.1 percentage of participants
|
68.1 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Pain: Moderate (n=284, 129)
|
20.1 percentage of participants
|
17.8 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Pain: Severe (n=261, 116)
|
2.3 percentage of participants
|
0.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Limitation of arm movement: Any (n=289, 130)
|
23.5 percentage of participants
|
18.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Limitation of arm movement: Mild (n=286, 130)
|
22.7 percentage of participants
|
16.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Limitation of arm movement: Moderate (n=260, 115)
|
1.2 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Limitation of arm movement: Severe (n=261, 115)
|
1.1 percentage of participants
|
1.7 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)Population: Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 23vPS and 13vPnC / 23vPS, respectively. Participants may be represented in more than 1 category.
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \[cm\]); Moderate (5.1 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Outcome measures
| Measure |
13vPnC / 23vPS
n=180 Participants
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
|
23vPS
n=234 Participants
23vPS administered as a single dose 0.5 mL IM at Year 0.
|
23vPS / 13vPnC
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Redness: Any (n=134, 151)
|
11.2 percentage of participants
|
27.8 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Redness: Mild (n=134, 144)
|
9.7 percentage of participants
|
19.4 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Redness: Moderate (n=128, 138)
|
3.9 percentage of participants
|
12.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Redness: Severe (n=127, 131)
|
0.8 percentage of participants
|
6.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Swelling: Any (n=135, 155)
|
10.4 percentage of participants
|
25.8 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Swelling: Mild (n=132, 149)
|
6.1 percentage of participants
|
20.1 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Swelling: Moderate (n=132, 138)
|
7.6 percentage of participants
|
12.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Swelling: Severe (n=127, 132)
|
0.0 percentage of participants
|
6.1 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Pain: Any (n=175, 231)
|
58.3 percentage of participants
|
85.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Pain: Mild (n=170, 205)
|
52.9 percentage of participants
|
78.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Pain: Moderate (n=143, 176)
|
21.7 percentage of participants
|
49.4 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Pain: Severe (n=127, 140)
|
0.8 percentage of participants
|
12.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Limitation of arm movement: Any (n=142, 178)
|
28.2 percentage of participants
|
53.4 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Limitation of arm movement: Mild (n=142, 171)
|
26.1 percentage of participants
|
47.4 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Limitation of arm movement: Moderate (n=127, 134)
|
3.1 percentage of participants
|
10.4 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Limitation of arm movement: Severe (n=128, 135)
|
2.3 percentage of participants
|
8.1 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)Population: Safety population; N=number of participants with any local reaction; (n)=number of participants with known values for 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \[cm\]; Moderate (5.1 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating); Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Outcome measures
| Measure |
13vPnC / 23vPS
n=130 Participants
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
|
23vPS
n=234 Participants
23vPS administered as a single dose 0.5 mL IM at Year 0.
|
23vPS / 13vPnC
n=171 Participants
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Redness: Any (n=86, 151, 115)
|
12.8 percentage of participants
|
27.8 percentage of participants
|
4.3 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Redness: Mild (n=83, 144, 115)
|
7.2 percentage of participants
|
19.4 percentage of participants
|
4.3 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Redness: Moderate (n=83, 138, 115)
|
7.2 percentage of participants
|
12.3 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Redness: Severe (n=83, 131, 115)
|
2.4 percentage of participants
|
6.9 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Swelling: Any (n=86, 155, 119)
|
14.0 percentage of participants
|
25.8 percentage of participants
|
5.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Swelling: Mild (n=85, 149, 119)
|
10.6 percentage of participants
|
20.1 percentage of participants
|
5.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Swelling: Moderate (n=82, 138, 116)
|
6.1 percentage of participants
|
12.3 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Swelling: Severe (n=82, 132, 115)
|
1.2 percentage of participants
|
6.1 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Pain: Any (n=129, 231, 169)
|
75.2 percentage of participants
|
85.7 percentage of participants
|
69.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Pain: Mild (n=123, 205, 166)
|
72.4 percentage of participants
|
78.5 percentage of participants
|
68.1 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Pain: Moderate (n=91, 176, 129)
|
24.2 percentage of participants
|
49.4 percentage of participants
|
17.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Pain: Severe (n=83, 140, 116)
|
2.4 percentage of participants
|
12.9 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Limitation of arm movement: Any (n=93, 178, 130)
|
28.0 percentage of participants
|
53.4 percentage of participants
|
18.5 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Limitation of arm movement: Mild (n=92, 171, 130)
|
27.2 percentage of participants
|
47.4 percentage of participants
|
16.9 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Limitation of arm movement: Moderate(n=83,134,115)
|
3.6 percentage of participants
|
10.4 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Limitation of arm movement: Severe (n=82, 135,115)
|
1.2 percentage of participants
|
8.1 percentage of participants
|
1.7 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1])Population: Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 23vPS, respectively. Participants may be represented in more than 1 category.
Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius \[C\], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC / 23vPS
n=383 Participants
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
|
23vPS
n=202 Participants
23vPS administered as a single dose 0.5 mL IM at Year 0.
|
23vPS / 13vPnC
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Fever: Any ≥38 degrees C (n=263, 127)
|
4.6 percentage of participants
|
1.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Fever: Mild ≥38 but <38.5 degrees C (n=263, 127)
|
3.8 percentage of participants
|
0.8 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Fever: Moderate ≥38.5 but <39 degrees C(n=259,127)
|
0.8 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Fever: Severe ≥39 but ≤40 degrees C (n=259, 127)
|
0.4 percentage of participants
|
0.8 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Fever Potentially life threatening >40C(n=258,127)
|
0.4 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Fatigue (n=321, 173)
|
50.5 percentage of participants
|
49.1 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Headache (n=328, 167)
|
49.7 percentage of participants
|
46.1 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Chills (n=286, 145)
|
19.9 percentage of participants
|
26.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Rash (n=267, 134)
|
8.6 percentage of participants
|
13.4 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Vomiting (n=261, 131)
|
3.1 percentage of participants
|
3.1 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Decreased appetite (n=278, 148)
|
14.7 percentage of participants
|
23.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
New muscle pain (n=324, 167)
|
46.9 percentage of participants
|
51.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Aggravated muscle pain (n=286, 154)
|
22.0 percentage of participants
|
32.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
New joint pain (n=278, 147)
|
15.5 percentage of participants
|
23.81 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1 (Year 0) 13vPnC and 23vPS
Aggravated joint pain (n=272, 142)
|
14.0 percentage of participants
|
21.1 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)Population: Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 13vPnC / 13vPnC, respectively. Participants may be represented in more than 1 category.
Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius \[C\], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC / 23vPS
n=102 Participants
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
|
23vPS
n=102 Participants
23vPS administered as a single dose 0.5 mL IM at Year 0.
|
23vPS / 13vPnC
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Fever: Any ≥38 degrees C (n=55, 55)
|
9.1 percentage of participants
|
3.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Fever: Mild ≥38 but <38.5 degrees C (n=55, 55)
|
7.3 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Fever: Moderate ≥38.5 but <39 degrees C(n=55, 55)
|
0.0 percentage of participants
|
1.8 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Fever: Severe ≥39 but ≤40 degrees C (n=55, 55)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Fever Potentially life threatening >40C (n=55, 55)
|
1.8 percentage of participants
|
1.8 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Fatigue (n=76, 76)
|
56.6 percentage of participants
|
43.4 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Headache (n=76, 76)
|
52.6 percentage of participants
|
44.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Chills (n=61, 61)
|
18.0 percentage of participants
|
19.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Rash (n=60, 60)
|
8.3 percentage of participants
|
10.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Vomiting (n=56, 56)
|
7.1 percentage of participants
|
3.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Decreased appetite (n=61, 61)
|
13.1 percentage of participants
|
21.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
New muscle pain (n=84, 84)
|
47.6 percentage of participants
|
51.2 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Aggravated muscle pain (n=68, 68)
|
26.5 percentage of participants
|
30.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
New joint pain (n=62, 62)
|
14.5 percentage of participants
|
16.1 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1)
Aggravated joint pain (n=62, 62)
|
16.1 percentage of participants
|
19.4 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)Population: Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC and 23vPS / 13vPnC , respectively. Participants may be represented in more than 1 category.
Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius \[C\], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC / 23vPS
n=383 Participants
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
|
23vPS
n=169 Participants
23vPS administered as a single dose 0.5 mL IM at Year 0.
|
23vPS / 13vPnC
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Fever: Moderate ≥38.5 but <39 degrees C(n=259,115)
|
0.8 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Fever: Severe ≥39 but ≤40 degrees C(n=259,115)
|
0.4 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Fever Potentially life threatening >40C(n=258,115)
|
0.4 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Fatigue (n=321, 141)
|
50.5 percentage of participants
|
41.1 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Headache (n=328, 139)
|
49.7 percentage of participants
|
40.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Fever: Any ≥38 degrees C (n=263, 116)
|
4.6 percentage of participants
|
0.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Fever: Mild ≥38 but <38.5 degrees C (n=263, 116)
|
3.8 percentage of participants
|
0.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Chills (n=286, 127)
|
19.9 percentage of participants
|
19.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Rash (n=267, 121)
|
8.6 percentage of participants
|
8.3 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Vomiting (n=261, 118)
|
3.1 percentage of participants
|
6.8 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Decreased appetite (n=278, 123)
|
14.7 percentage of participants
|
13.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
New muscle pain (n=324, 151)
|
46.9 percentage of participants
|
45.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Aggravated muscle pain (n=286, 136)
|
22.0 percentage of participants
|
28.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
New joint pain (n=278, 128)
|
15.5 percentage of participants
|
19.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1)
Aggravated joint pain (n=272, 131)
|
14.0 percentage of participants
|
21.4 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)Population: Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 23vPS and 13vPnC / 23vPS, respectively. Participants may be represented in more than 1 category.
Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius \[C\], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC / 23vPS
n=202 Participants
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
|
23vPS
n=175 Participants
23vPS administered as a single dose 0.5 mL IM at Year 0.
|
23vPS / 13vPnC
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Fever: Any ≥38 degrees C (n=127, 129)
|
1.6 percentage of participants
|
3.1 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Fever: Mild ≥38 but <38.5 degrees C (n=127, 129)
|
0.8 percentage of participants
|
3.1 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Fever: Moderate ≥38.5 but <39 degrees C(n=127,127)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Fever: Severe ≥39 but ≤40 degrees C(n=127,127)
|
0.8 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Fever Potentially life threatening >40C(n=127,127)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Fatigue (n=173, 185)
|
49.1 percentage of participants
|
51.9 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Headache (n=167, 175)
|
46.1 percentage of participants
|
49.7 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Chills (n=145, 155)
|
26.9 percentage of participants
|
29.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Rash (n=134, 146)
|
13.4 percentage of participants
|
24.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Vomiting (n=131, 131)
|
3.1 percentage of participants
|
4.6 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Decreased appetite (n=148, 141)
|
23.0 percentage of participants
|
17.0 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
New muscle pain (n=167, 196)
|
51.5 percentage of participants
|
61.2 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Aggravated muscle pain (n=154, 164)
|
32.5 percentage of participants
|
41.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
New joint pain (n=147, 153)
|
23.8 percentage of participants
|
25.5 percentage of participants
|
—
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 23vPS (Year 0) and 13vPnC / 23vPS (Year 1)
Aggravated joint pain (n=142, 143)
|
21.1 percentage of participants
|
17.5 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)Population: Safety population; N=number of participants with any systemic event; (n)=number of participants with known values for 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC, respectively. Participants may be represented in more than 1 category.
Systemic events reported using an electronic diary. Systemic events are any fever ≥38 degrees Celsius \[C\], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain (new muscle pain), aggravated generalized muscle pain (aggravated muscle pain), new generalized joint pain (new joint pain), and aggravated generalized joint pain (aggravated joint pain). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC / 23vPS
n=117 Participants
13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
|
23vPS
n=222 Participants
23vPS administered as a single dose 0.5 mL IM at Year 0.
|
23vPS / 13vPnC
n=169 Participants
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
|---|---|---|---|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Vomiting (n=82, 131, 118)
|
3.7 percentage of participants
|
4.6 percentage of participants
|
6.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Decreased appetite (n=89, 141, 123)
|
18.0 percentage of participants
|
17.0 percentage of participants
|
13.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Fever: Any ≥38 degrees C (n=81, 129, 116)
|
2.5 percentage of participants
|
3.1 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Fever: Mild ≥38 but <38.5 degrees C (n=81,129,116)
|
0.0 percentage of participants
|
3.1 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Fever: Moderate ≥38.5, <39 degrees C(n=81,127,115)
|
1.2 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Fever: Severe ≥39, ≤40 degrees C(n=81,127,115)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Potentially life threatening >40C(n=81,127,115)
|
1.2 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Fatigue (n=100, 185, 141)
|
39.0 percentage of participants
|
51.9 percentage of participants
|
41.1 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Headache (n=96, 175, 139)
|
41.7 percentage of participants
|
49.7 percentage of participants
|
40.3 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Chills (n=90, 155, 127)
|
18.9 percentage of participants
|
29.0 percentage of participants
|
19.7 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Rash (n=86, 146, 121)
|
10.5 percentage of participants
|
24.0 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
New muscle pain (n=108, 196, 151)
|
50.0 percentage of participants
|
61.2 percentage of participants
|
45.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Aggravated muscle pain (n=94, 164, 136)
|
26.6 percentage of participants
|
41.5 percentage of participants
|
28.7 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
New joint pain (n=87, 153, 128)
|
14.9 percentage of participants
|
25.5 percentage of participants
|
19.5 percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 1) 13vPnC / 13vPnC, 13vPnC / 23vPS, and 23vPS / 13vPnC
Aggravated joint pain (n=91, 143, 131)
|
17.6 percentage of participants
|
17.5 percentage of participants
|
21.4 percentage of participants
|
Adverse Events
13vPnC / 13vPnC (Year 1)
Serious events: 0 serious events
Other events: 97 other events
Deaths: 0 deaths
13vPnC / 23vPS (Year 1)
Serious events: 2 serious events
Other events: 198 other events
Deaths: 0 deaths
23vPS / 13vPnC (Year 1)
Serious events: 1 serious events
Other events: 118 other events
Deaths: 0 deaths
13vPnC / 13vPnC: 6 Month Follow-up After Vax 2 (Year 1)
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
13vPnC / 23vPS: 6 Month Follow-up After Vax 2 (Year 1)
Serious events: 6 serious events
Other events: 23 other events
Deaths: 0 deaths
23vPS / 13vPnC: 6 Month Follow-up After Vax 2 (Year 1)
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
13vPnC (Year 0)
Serious events: 2 serious events
Other events: 256 other events
Deaths: 0 deaths
23vPS (Year 0)
Serious events: 1 serious events
Other events: 102 other events
Deaths: 0 deaths
13vPnC: 6 Month Follow-up After Vax 1 (Year 0)
Serious events: 15 serious events
Other events: 41 other events
Deaths: 0 deaths
23vPS: 6 Month Follow-up After Vax 1 (Year 0)
Serious events: 6 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC / 13vPnC (Year 1)
n=160 participants at risk
13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=22; systematic (solicited) Local Reactions N=97; systematic (solicited) Systemic Events N=54.
|
13vPnC / 23vPS (Year 1)
n=267 participants at risk
13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=50; systematic (solicited) Local Reactions N=198; systematic (solicited) Systemic Events N=120.
|
23vPS / 13vPnC (Year 1)
n=223 participants at risk
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=32; systematic (solicited) Local Reactions N=118; systematic (solicited) Systemic Events N=68.
|
13vPnC / 13vPnC: 6 Month Follow-up After Vax 2 (Year 1)
n=160 participants at risk
13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
13vPnC / 23vPS: 6 Month Follow-up After Vax 2 (Year 1)
n=267 participants at risk
13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
|
23vPS / 13vPnC: 6 Month Follow-up After Vax 2 (Year 1)
n=223 participants at risk
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
13vPnC (Year 0)
n=478 participants at risk
Group 1.1: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=90; systematic (solicited) Local Reactions N=256; systematic (solicited) Systemic Events N=163.
|
23vPS (Year 0)
n=237 participants at risk
Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=49; systematic (solicited) Local Reactions N=102; systematic (solicited) Systemic Events N=86.
|
13vPnC: 6 Month Follow-up After Vax 1 (Year 0)
n=478 participants at risk
Group 1.1: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
|
23vPS: 6 Month Follow-up After Vax 1 (Year 0)
n=237 participants at risk
Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Endocrine disorders
Goitre
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Cellulitis orbital
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.2%
2/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Reproductive system and breast disorders
Ovarian adhesion
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
Other adverse events
| Measure |
13vPnC / 13vPnC (Year 1)
n=160 participants at risk
13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=22; systematic (solicited) Local Reactions N=97; systematic (solicited) Systemic Events N=54.
|
13vPnC / 23vPS (Year 1)
n=267 participants at risk
13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=50; systematic (solicited) Local Reactions N=198; systematic (solicited) Systemic Events N=120.
|
23vPS / 13vPnC (Year 1)
n=223 participants at risk
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=32; systematic (solicited) Local Reactions N=118; systematic (solicited) Systemic Events N=68.
|
13vPnC / 13vPnC: 6 Month Follow-up After Vax 2 (Year 1)
n=160 participants at risk
13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
13vPnC / 23vPS: 6 Month Follow-up After Vax 2 (Year 1)
n=267 participants at risk
13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
|
23vPS / 13vPnC: 6 Month Follow-up After Vax 2 (Year 1)
n=223 participants at risk
23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
13vPnC (Year 0)
n=478 participants at risk
Group 1.1: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=90; systematic (solicited) Local Reactions N=256; systematic (solicited) Systemic Events N=163.
|
23vPS (Year 0)
n=237 participants at risk
Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=49; systematic (solicited) Local Reactions N=102; systematic (solicited) Systemic Events N=86.
|
13vPnC: 6 Month Follow-up After Vax 1 (Year 0)
n=478 participants at risk
Group 1.1: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
|
23vPS: 6 Month Follow-up After Vax 1 (Year 0)
n=237 participants at risk
Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Congenital, familial and genetic disorders
Mixed hyperlipidaemia
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Congenital, familial and genetic disorders
Gastrointestinal malformation
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Endocrine disorders
Testicular failure
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Endocrine disorders
Androgen deficiency
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Eye disorders
Eyelid pain
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Eye disorders
Glaucoma
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Eye disorders
Eyelid irritation
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Eye disorders
Maculopathy
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/22 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.63%
3/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.84%
2/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
2/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.63%
3/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
2/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
2/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Vomiting
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Malabsorption
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Injection site erythema
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.84%
4/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Injection site haematoma
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.90%
2/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.63%
3/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Fatigue
|
39.0%
39/100 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
51.9%
96/185 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
41.1%
58/141 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Injection site pain
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.75%
2/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
2/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Chills
|
18.9%
17/90 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
29.0%
45/155 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
19.7%
25/127 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Influenza like illness
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Injection site induration
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Injection site swelling
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Pyrexia
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Cyst
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Injection site rash
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Immune system disorders
Allergy to vaccine
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
4/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.5%
4/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.9%
9/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
2.5%
6/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
2/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
2.2%
6/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.90%
2/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.5%
7/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
3.4%
8/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Influenza
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.5%
7/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.84%
2/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Sinusitis
|
1.9%
3/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.1%
3/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.3%
6/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Bronchitis
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.5%
4/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.3%
3/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.84%
4/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.84%
2/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
2/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.63%
3/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
2/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.84%
2/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.84%
2/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Otitis media
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Ear infection
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.75%
2/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
2/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
2/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Investigations
Body temperature decreased
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Investigations
Haemoglobin increased
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Investigations
Blood pressure increased
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Investigations
Weight increased
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Investigations
Blood testosterone decreased
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.2%
2/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.84%
4/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.3%
3/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.90%
2/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.90%
2/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
2/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.84%
2/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
2/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.84%
2/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Bursa disorder
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.90%
2/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.1%
3/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.84%
2/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.75%
2/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.75%
2/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.75%
2/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Nodal osteoarthritis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Enthesopathy
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
2/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Nervous system disorders
Headache
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.75%
2/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
2/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Nervous system disorders
Restless legs syndrome
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
2/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Psychiatric disorders
Sleep disorder due to a general medical condition
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Psychiatric disorders
Sleep disorder due to general medical condition, insomnia type
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
2/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.1%
3/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.90%
2/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.84%
4/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.84%
2/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.84%
4/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.84%
2/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.84%
4/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.75%
2/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
2/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.90%
2/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cyst
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
2/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Xanthoma
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Social circumstances
Postmenopause
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.90%
2/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.1%
3/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
2/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.0%
5/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Vascular disorders
Hypotension
|
0.62%
1/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Vascular disorders
Orthostatic hypertension
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.21%
1/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.42%
1/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Vascular disorders
Venous valve ruptured
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.37%
1/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/160 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/267 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.45%
1/223 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/478 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/237 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Redness (Any)
|
12.8%
11/86 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
27.8%
42/151 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
4.3%
5/115 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Redness (Mild)
|
7.2%
6/83 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
19.4%
28/144 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
4.3%
5/115 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Redness (Moderate)
|
7.2%
6/83 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
12.3%
17/138 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.87%
1/115 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Redness (Severe)
|
2.4%
2/83 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
6.9%
9/131 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/115 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Swelling (Any)
|
14.0%
12/86 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
25.8%
40/155 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
5.0%
6/119 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Swelling (Mild)
|
10.6%
9/85 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
20.1%
30/149 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
5.0%
6/119 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Swelling (Moderate)
|
6.1%
5/82 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
12.3%
17/138 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.86%
1/116 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Swelling (Severe)
|
1.2%
1/82 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
6.1%
8/132 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/115 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Pain (Any)
|
75.2%
97/129 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
85.7%
198/231 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
69.8%
118/169 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Pain (Mild)
|
72.4%
89/123 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
78.5%
161/205 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
68.1%
113/166 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Pain (Moderate)
|
24.2%
22/91 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
49.4%
87/176 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
17.8%
23/129 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Pain (Severe)
|
2.4%
2/83 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
12.9%
18/140 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.86%
1/116 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Limitation of arm movement (Any)
|
28.0%
26/93 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
53.4%
95/178 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
18.5%
24/130 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Limitation of arm movement (Mild)
|
27.2%
25/92 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
47.4%
81/171 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
16.9%
22/130 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Limitation of arm movement (Moderate)
|
3.6%
3/83 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
10.4%
14/134 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/115 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
Skin and subcutaneous tissue disorders
Limitation of arm movement (Severe)
|
1.2%
1/82 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
8.1%
11/135 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
1.7%
2/115 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Fever (Any)
|
2.5%
2/81 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
3.1%
4/129 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.86%
1/116 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Fever (Mild)
|
0.00%
0/81 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
3.1%
4/129 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.86%
1/116 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Fever (Moderate)
|
1.2%
1/81 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/127 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/115 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Fever (Severe)
|
0.00%
0/81 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/127 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/115 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Fever (Potentially life threatening)
|
1.2%
1/81 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/127 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
0.00%
0/115 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Headache
|
41.7%
40/96 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
49.7%
87/175 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
40.3%
56/139 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Rash
|
10.5%
9/86 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
24.0%
35/146 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
8.3%
10/121 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Vomiting
|
3.7%
3/82 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
4.6%
6/131 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
6.8%
8/118 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Decreased appetite
|
18.0%
16/89 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
17.0%
24/141 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
13.0%
16/123 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
New generalized muscle pain
|
50.0%
54/108 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
61.2%
120/196 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
45.0%
68/151 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Aggravated generalized muscle pain
|
26.6%
25/94 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
41.5%
68/164 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
28.7%
39/136 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
New generalized joint pain
|
14.9%
13/87 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
25.5%
39/153 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
19.5%
25/128 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
|
General disorders
Aggravated generalized joint pain
|
17.6%
16/91 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
17.5%
25/143 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
21.4%
28/131 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
—
0/0 • Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).
Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may=serious for 1 subject and=non-serious for another subject or subject may have experienced both a serious and non-serious episode of same event. AEs/SAEs=non-systematic assessment; local reactions and systemic events=systematic assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER