Trial Outcomes & Findings for Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults (NCT NCT00427895)
NCT ID: NCT00427895
Last Updated: 2021-11-15
Results Overview
Serotype-specific OPA GMTs for the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using microcolony OPA (mcOPA) assay. CIs for GMT 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
2141 participants
Primary outcome timeframe
One month after vaccination 1
Results posted on
2021-11-15
Participant Flow
Participants in Cohort 1 and 2 participated for 1 year in the study. Vaccination 2 (3 to 4 years after vaccination 1) was administered to participants in Cohort 1 and 2. Participants in Cohort 3 enrolled as part of amendment 3 participated for 6 months and participants in Cohort 3 enrolled as part of amendment 4 participated for 1 year in study.
Participant milestones
| Measure |
13vPnC, Cohort 1
Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 \[Vax1\]) at baseline.
|
23vPS, Cohort 1
Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1) at baseline.
|
13vPnC, Cohort 2
Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly at (Vaccination 1) at baseline.
|
13vPnC, Cohort 3
Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1) at baseline.
|
13vPnC/13vPnC, Cohort 1
Participants 60-64 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 13vPnC (Vaccination 2) at Year 3 to 4.
|
13vPnC/23vPS, Cohort 1
Participants 60-64 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 23vPS (Vaccination 2) at Year 3 to 4.
|
23vPS/23vPS, Cohort 1
Participants 60-64 years of age who received 23vPS at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/13vPnC, Cohort 2
Participants 50-59 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 13vPnC (Vaccination 2) at Year 3 to 4.
|
|---|---|---|---|---|---|---|---|---|
|
Between 6-Month Follow-up - Year 1
STARTED
|
411
|
411
|
392
|
854
|
0
|
0
|
0
|
0
|
|
Between 6-Month Follow-up - Year 1
COMPLETED
|
411
|
411
|
392
|
502
|
0
|
0
|
0
|
0
|
|
Between 6-Month Follow-up - Year 1
NOT COMPLETED
|
0
|
0
|
0
|
352
|
0
|
0
|
0
|
0
|
|
Vax 2/Year 3 to 4
STARTED
|
0
|
0
|
0
|
0
|
108
|
108
|
189
|
214
|
|
Vax 2/Year 3 to 4
COMPLETED
|
0
|
0
|
0
|
0
|
107
|
108
|
189
|
212
|
|
Vax 2/Year 3 to 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
2
|
|
Vax 1 Baseline/6-Month Follow-up
STARTED
|
418
|
417
|
406
|
900
|
0
|
0
|
0
|
0
|
|
Vax 1 Baseline/6-Month Follow-up
Vaccinated
|
417
|
414
|
404
|
899
|
0
|
0
|
0
|
0
|
|
Vax 1 Baseline/6-Month Follow-up
COMPLETED
|
411
|
411
|
392
|
854
|
0
|
0
|
0
|
0
|
|
Vax 1 Baseline/6-Month Follow-up
NOT COMPLETED
|
7
|
6
|
14
|
46
|
0
|
0
|
0
|
0
|
|
Vax 1/Year 1 Follow-up
STARTED
|
411
|
411
|
392
|
502
|
0
|
0
|
0
|
0
|
|
Vax 1/Year 1 Follow-up
COMPLETED
|
404
|
396
|
373
|
469
|
0
|
0
|
0
|
0
|
|
Vax 1/Year 1 Follow-up
NOT COMPLETED
|
7
|
15
|
19
|
33
|
0
|
0
|
0
|
0
|
|
Between Year 1 - Vax 2/Year 3 to 4
STARTED
|
404
|
396
|
373
|
469
|
0
|
0
|
0
|
0
|
|
Between Year 1 - Vax 2/Year 3 to 4
COMPLETED
|
216
|
189
|
214
|
0
|
0
|
0
|
0
|
0
|
|
Between Year 1 - Vax 2/Year 3 to 4
NOT COMPLETED
|
188
|
207
|
159
|
469
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
13vPnC, Cohort 1
Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 \[Vax1\]) at baseline.
|
23vPS, Cohort 1
Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1) at baseline.
|
13vPnC, Cohort 2
Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly at (Vaccination 1) at baseline.
|
13vPnC, Cohort 3
Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1) at baseline.
|
13vPnC/13vPnC, Cohort 1
Participants 60-64 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 13vPnC (Vaccination 2) at Year 3 to 4.
|
13vPnC/23vPS, Cohort 1
Participants 60-64 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 23vPS (Vaccination 2) at Year 3 to 4.
|
23vPS/23vPS, Cohort 1
Participants 60-64 years of age who received 23vPS at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/13vPnC, Cohort 2
Participants 50-59 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 13vPnC (Vaccination 2) at Year 3 to 4.
|
|---|---|---|---|---|---|---|---|---|
|
Between 6-Month Follow-up - Year 1
Did not enter 1-year blood draw
|
0
|
0
|
0
|
352
|
0
|
0
|
0
|
0
|
|
Vax 2/Year 3 to 4
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Vax 2/Year 3 to 4
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Vax 2/Year 3 to 4
Failed to Return
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Vax 1 Baseline/6-Month Follow-up
Lost to Follow-up
|
0
|
1
|
4
|
32
|
0
|
0
|
0
|
0
|
|
Vax 1 Baseline/6-Month Follow-up
Protocol Violation
|
4
|
0
|
3
|
2
|
0
|
0
|
0
|
0
|
|
Vax 1 Baseline/6-Month Follow-up
Physician Decision
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Vax 1 Baseline/6-Month Follow-up
Withdrawal by Subject
|
1
|
1
|
4
|
7
|
0
|
0
|
0
|
0
|
|
Vax 1 Baseline/6-Month Follow-up
Failed to Return
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Vax 1 Baseline/6-Month Follow-up
Randomized, Not Vaccinated
|
1
|
3
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Vax 1 Baseline/6-Month Follow-up
Other
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Vax 1/Year 1 Follow-up
Lost to Follow-up
|
0
|
5
|
2
|
21
|
0
|
0
|
0
|
0
|
|
Vax 1/Year 1 Follow-up
Protocol Violation
|
3
|
3
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Vax 1/Year 1 Follow-up
Withdrawal by Subject
|
3
|
6
|
5
|
4
|
0
|
0
|
0
|
0
|
|
Vax 1/Year 1 Follow-up
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Vax 1/Year 1 Follow-up
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Vax 1/Year 1 Follow-up
Failed to Return
|
0
|
0
|
12
|
5
|
0
|
0
|
0
|
0
|
|
Vax 1/Year 1 Follow-up
Other
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Between Year 1 - Vax 2/Year 3 to 4
Did Not Consent to Receive Vax 2
|
188
|
207
|
159
|
469
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults
Baseline characteristics by cohort
| Measure |
13vPnC, Cohort 1
n=417 Participants
Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 \[Vax1\]).
|
23vPS, Cohort 1
n=414 Participants
Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
|
13vPnC, Cohort 2
n=403 Participants
Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
|
13vPnC, Cohort 3
n=899 Participants
Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
|
Total
n=2133 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18 to 29 years
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
300 participants
n=483 Participants
|
300 participants
n=36 Participants
|
|
Age, Customized
30 to 39 years
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
298 participants
n=483 Participants
|
298 participants
n=36 Participants
|
|
Age, Customized
40 to 49 years
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
301 participants
n=483 Participants
|
301 participants
n=36 Participants
|
|
Age, Customized
50 to 59 years
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
403 participants
n=27 Participants
|
0 participants
n=483 Participants
|
403 participants
n=36 Participants
|
|
Age, Customized
60 to 64 years
|
417 participants
n=93 Participants
|
414 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
831 participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
223 Participants
n=93 Participants
|
252 Participants
n=4 Participants
|
249 Participants
n=27 Participants
|
523 Participants
n=483 Participants
|
1247 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
194 Participants
n=93 Participants
|
162 Participants
n=4 Participants
|
154 Participants
n=27 Participants
|
376 Participants
n=483 Participants
|
886 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: One month after vaccination 1Population: Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.
Serotype-specific OPA GMTs for the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Outcome measures
| Measure |
13vPnC/13vPnC, Cohort 1
n=411 Participants
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 \[Vax2\]) at Year 3 to 4.
|
23vPS/23vPS, Cohort 1
n=407 Participants
Participants aged 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/23vPS, Cohort 1
n=388 Participants
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/13vPnC, Cohort 2
n=874 Participants
Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
|
|---|---|---|---|---|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
1
|
146 titer
Interval 124.0 to 172.9
|
104 titer
Interval 87.7 to 124.4
|
200 titer
Interval 170.3 to 236.0
|
353 titer
Interval 322.8 to 386.9
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
3
|
93 titer
Interval 81.1 to 106.6
|
85 titer
Interval 74.2 to 98.3
|
91 titer
Interval 79.9 to 104.7
|
91 titer
Interval 84.2 to 98.4
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
5
|
199 titer
Interval 164.0 to 242.3
|
162 titer
Interval 133.6 to 197.5
|
269 titer
Interval 218.1 to 332.5
|
386 titer
Interval 342.6 to 435.8
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
6A
|
2593 titer
Interval 2146.7 to 3131.1
|
213 titer
Interval 160.3 to 284.3
|
4328 titer
Interval 3658.1 to 5121.5
|
5746 titer
Interval 5240.7 to 6300.4
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
6B
|
1984 titer
Interval 1604.0 to 2453.6
|
788 titer
Interval 615.9 to 1008.5
|
3212 titer
Interval 2728.6 to 3781.4
|
9813 titer
Interval 9097.8 to 10583.5
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
7F
|
1120 titer
Interval 907.6 to 1382.9
|
405 titer
Interval 311.9 to 524.7
|
1520 titer
Interval 1274.5 to 1812.1
|
3249 titer
Interval 2994.8 to 3523.9
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
9V
|
1164 titer
Interval 934.8 to 1448.3
|
407 titer
Interval 307.2 to 539.8
|
1726 titer
Interval 1428.5 to 2086.2
|
3339 titer
Interval 3037.4 to 3670.4
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
19A
|
682 titer
Interval 596.5 to 779.9
|
352 titer
Interval 297.0 to 416.1
|
956 titer
Interval 837.6 to 1090.7
|
1580 titer
Interval 1471.4 to 1696.3
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
19F
|
517 titer
Interval 420.8 to 635.3
|
539 titer
Interval 442.1 to 658.2
|
599 titer
Interval 491.0 to 731.0
|
1533 titer
Interval 1397.3 to 1680.9
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
23F
|
375 titer
Interval 297.2 to 472.6
|
72 titer
Interval 55.9 to 93.4
|
494 titer
Interval 386.8 to 630.7
|
1570 titer
Interval 1392.8 to 1770.2
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
4
|
2062 titer
Interval 1693.6 to 2510.5
|
1295 titer
Interval 1045.9 to 1603.0
|
2833 titer
Interval 2412.1 to 3327.4
|
4747 titer
Interval 4370.2 to 5155.5
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
14
|
612 titer
Interval 489.6 to 764.2
|
692 titer
Interval 553.3 to 866.2
|
957 titer
Interval 779.6 to 1174.5
|
2983 titer
Interval 2740.5 to 3246.6
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
18C
|
1726 titer
Interval 1429.7 to 2082.9
|
925 titer
Interval 735.3 to 1162.9
|
1939 titer
Interval 1599.2 to 2350.2
|
3989 titer
Interval 3629.4 to 4383.8
|
PRIMARY outcome
Timeframe: One month after vaccination 1Population: Evaluable immunogenicity population; N (number of participants analyzed) signifies participants with determinate OPA antibody titer to serotype 6A.
For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
Outcome measures
| Measure |
13vPnC/13vPnC, Cohort 1
n=374 Participants
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 \[Vax2\]) at Year 3 to 4.
|
23vPS/23vPS, Cohort 1
n=377 Participants
Participants aged 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/23vPS, Cohort 1
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/13vPnC, Cohort 2
Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1
|
88.5 percentage of participants
Interval 84.8 to 91.6
|
49.3 percentage of participants
Interval 44.2 to 54.5
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after vaccination 1 and One month after vaccination 2/Year 3 to 4Population: Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.
Serotype-specific OPA GMTs for the 12 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Outcome measures
| Measure |
13vPnC/13vPnC, Cohort 1
n=108 Participants
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 \[Vax2\]) at Year 3 to 4.
|
23vPS/23vPS, Cohort 1
n=407 Participants
Participants aged 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/23vPS, Cohort 1
n=189 Participants
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/13vPnC, Cohort 2
Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
|
|---|---|---|---|---|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group
1
|
398 titers
Interval 306.2 to 516.3
|
116 titers
Interval 89.4 to 149.6
|
95 titers
Interval 74.8 to 121.1
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group
3
|
164 titers
Interval 129.0 to 207.5
|
105 titers
Interval 85.3 to 128.7
|
53 titers
Interval 42.8 to 64.4
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group
4
|
1875 titers
Interval 1488.8 to 2360.7
|
1420 titers
Interval 1066.2 to 1890.5
|
733 titers
Interval 555.1 to 968.2
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group
5
|
476 titers
Interval 356.2 to 636.1
|
149 titers
Interval 111.1 to 201.2
|
74 titers
Interval 54.2 to 100.3
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group
6B
|
2670 titers
Interval 2012.9 to 3540.6
|
1088 titers
Interval 774.7 to 1528.1
|
916 titers
Interval 670.0 to 1252.4
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group
7F
|
1895 titers
Interval 1471.0 to 2441.1
|
403 titers
Interval 276.3 to 588.9
|
497 titers
Interval 361.8 to 682.0
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group
18C
|
2489 titers
Interval 1941.1 to 3192.7
|
1135 titers
Interval 815.7 to 1578.6
|
802 titers
Interval 597.5 to 1076.8
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group
19A
|
966 titers
Interval 763.2 to 1223.6
|
377 titers
Interval 296.1 to 479.6
|
364 titers
Interval 290.0 to 458.0
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group
9V
|
1089 titers
Interval 699.2 to 1695.0
|
654 titers
Interval 452.5 to 944.9
|
187 titers
Interval 125.0 to 280.3
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group
14
|
1268 titers
Interval 951.8 to 1690.0
|
824 titers
Interval 612.9 to 1107.8
|
661 titers
Interval 515.6 to 848.6
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group
19F
|
1653 titers
Interval 1302.2 to 2099.5
|
621 titers
Interval 468.6 to 821.7
|
374 titers
Interval 286.1 to 488.2
|
—
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group
23F
|
299 titers
Interval 203.9 to 437.5
|
86 titers
Interval 58.8 to 124.5
|
54 titers
Interval 38.4 to 77.0
|
—
|
SECONDARY outcome
Timeframe: One month after vaccination 1Population: Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.
Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.
Outcome measures
| Measure |
13vPnC/13vPnC, Cohort 1
n=411 Participants
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 \[Vax2\]) at Year 3 to 4.
|
23vPS/23vPS, Cohort 1
n=407 Participants
Participants aged 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/23vPS, Cohort 1
n=388 Participants
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/13vPnC, Cohort 2
n=874 Participants
Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
3
|
92.1 Percentage of participants
Interval 89.0 to 94.6
|
88.3 Percentage of participants
Interval 84.7 to 91.3
|
92.3 Percentage of participants
Interval 89.2 to 94.8
|
94.8 Percentage of participants
Interval 93.1 to 96.2
|
|
Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
4
|
95.0 Percentage of participants
Interval 92.2 to 97.0
|
91.6 Percentage of participants
Interval 88.2 to 94.2
|
97.4 Percentage of participants
Interval 95.2 to 98.8
|
99.2 Percentage of participants
Interval 98.3 to 99.7
|
|
Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
7F
|
90.4 Percentage of participants
Interval 87.0 to 93.1
|
78.0 Percentage of participants
Interval 73.6 to 82.0
|
94.7 Percentage of participants
Interval 91.9 to 96.7
|
98.6 Percentage of participants
Interval 97.6 to 99.3
|
|
Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
19A
|
98.5 Percentage of participants
Interval 96.7 to 99.4
|
94.3 Percentage of participants
Interval 91.5 to 96.4
|
98.4 Percentage of participants
Interval 96.6 to 99.4
|
99.9 Percentage of participants
Interval 99.4 to 100.0
|
|
Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
5
|
87.0 Percentage of participants
Interval 83.3 to 90.2
|
84.7 Percentage of participants
Interval 80.8 to 88.1
|
86.1 Percentage of participants
Interval 82.1 to 89.4
|
92.1 Percentage of participants
Interval 90.1 to 93.8
|
|
Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
6A
|
95.8 Percentage of participants
Interval 93.3 to 97.5
|
69.1 Percentage of participants
Interval 64.3 to 73.7
|
97.9 Percentage of participants
Interval 95.9 to 99.1
|
99.4 Percentage of participants
Interval 98.6 to 99.8
|
|
Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
6B
|
93.5 Percentage of participants
Interval 90.5 to 95.8
|
86.0 Percentage of participants
Interval 82.0 to 89.4
|
97.5 Percentage of participants
Interval 95.3 to 98.9
|
99.9 Percentage of participants
Interval 99.4 to 100.0
|
|
Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
9V
|
89.9 Percentage of participants
Interval 86.4 to 92.8
|
75.8 Percentage of participants
Interval 71.1 to 80.1
|
93.7 Percentage of participants
Interval 90.7 to 96.0
|
97.7 Percentage of participants
Interval 96.5 to 98.6
|
|
Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
14
|
87.7 Percentage of participants
Interval 84.0 to 90.9
|
88.6 Percentage of participants
Interval 85.0 to 91.6
|
92.0 Percentage of participants
Interval 88.7 to 94.5
|
99.0 Percentage of participants
Interval 98.0 to 99.5
|
|
Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
18C
|
95.5 Percentage of participants
Interval 92.9 to 97.4
|
89.0 Percentage of participants
Interval 85.4 to 91.9
|
94.9 Percentage of participants
Interval 92.2 to 96.9
|
98.6 Percentage of participants
Interval 97.5 to 99.3
|
|
Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
19F
|
89.7 Percentage of participants
Interval 86.1 to 92.5
|
90.8 Percentage of participants
Interval 87.4 to 93.6
|
91.6 Percentage of participants
Interval 88.2 to 94.2
|
98.1 Percentage of participants
Interval 96.9 to 98.9
|
|
Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
23F
|
84.5 Percentage of participants
Interval 80.5 to 88.0
|
61.3 Percentage of participants
Interval 56.2 to 66.3
|
85.1 Percentage of participants
Interval 81.0 to 88.5
|
95.1 Percentage of participants
Interval 93.4 to 96.4
|
|
Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
1
|
90.3 Percentage of participants
Interval 87.0 to 93.0
|
83.8 Percentage of participants
Interval 79.9 to 87.3
|
94.0 Percentage of participants
Interval 91.1 to 96.1
|
97.6 Percentage of participants
Interval 96.3 to 98.5
|
SECONDARY outcome
Timeframe: Prevaccination 1 to 1 month after vaccination 2/Year 3 to 4Population: Evaluable immunogenicity population; n= number of participants with valid and determinate assay results for the specified serotype at both sampling times.
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Outcome measures
| Measure |
13vPnC/13vPnC, Cohort 1
n=108 Participants
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 \[Vax2\]) at Year 3 to 4.
|
23vPS/23vPS, Cohort 1
n=108 Participants
Participants aged 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/23vPS, Cohort 1
n=189 Participants
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/13vPnC, Cohort 2
n=211 Participants
Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
|
|---|---|---|---|---|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2
4
|
68.0 Fold Rise
Interval 40.04 to 115.58
|
110.4 Fold Rise
Interval 66.47 to 183.22
|
43.8 Fold Rise
Interval 27.87 to 68.74
|
104.2 Fold Rise
Interval 70.96 to 152.94
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2
5
|
47.9 Fold Rise
Interval 33.51 to 68.52
|
83.2 Fold Rise
Interval 60.56 to 114.26
|
11.9 Fold Rise
Interval 8.94 to 15.71
|
52.8 Fold Rise
Interval 41.81 to 66.71
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2
6A
|
142.0 Fold Rise
Interval 84.1 to 239.68
|
116.2 Fold Rise
Interval 71.19 to 189.69
|
6.4 Fold Rise
Interval 4.25 to 9.53
|
139.7 Fold Rise
Interval 93.99 to 207.79
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2
6B
|
103.3 Fold Rise
Interval 57.72 to 184.69
|
63.6 Fold Rise
Interval 34.73 to 116.29
|
24.9 Fold Rise
Interval 15.98 to 38.77
|
132.7 Fold Rise
Interval 84.86 to 207.38
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2
7F
|
140.8 Fold Rise
Interval 91.49 to 216.59
|
293.9 Fold Rise
Interval 203.35 to 424.67
|
72.1 Fold Rise
Interval 50.27 to 103.53
|
218.0 Fold Rise
Interval 169.33 to 280.62
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2
19F
|
54.1 Fold Rise
Interval 34.08 to 86.01
|
110.3 Fold Rise
Interval 71.3 to 170.65
|
25.1 Fold Rise
Interval 18.04 to 34.84
|
60.4 Fold Rise
Interval 43.4 to 84.06
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2
3
|
13.2 Fold Rise
Interval 9.98 to 17.33
|
21.2 Fold Rise
Interval 15.46 to 29.15
|
6.8 Fold Rise
Interval 5.49 to 8.54
|
11.5 Fold Rise
Interval 9.51 to 13.91
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2
1
|
72.6 Fold Rise
Interval 53.9 to 97.82
|
69.7 Fold Rise
Interval 51.85 to 93.79
|
15.6 Fold Rise
Interval 12.38 to 19.73
|
54.0 Fold Rise
Interval 43.92 to 66.5
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2
9V
|
24.7 Fold Rise
Interval 12.86 to 47.32
|
40.1 Fold Rise
Interval 21.13 to 76.11
|
10.6 Fold Rise
Interval 6.52 to 17.13
|
49.9 Fold Rise
Interval 32.88 to 75.68
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2
14
|
20.6 Fold Rise
Interval 12.31 to 34.57
|
36.6 Fold Rise
Interval 22.02 to 60.97
|
19.9 Fold Rise
Interval 13.85 to 28.67
|
26.6 Fold Rise
Interval 18.43 to 38.52
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2
18C
|
67.9 Fold Rise
Interval 41.02 to 112.48
|
80.9 Fold Rise
Interval 48.89 to 133.79
|
27.5 Fold Rise
Interval 19.1 to 39.69
|
94.9 Fold Rise
Interval 67.89 to 132.54
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2
19A
|
37.6 Fold Rise
Interval 25.57 to 55.37
|
43.1 Fold Rise
Interval 29.21 to 63.51
|
15.4 Fold Rise
Interval 11.79 to 20.25
|
30.9 Fold Rise
Interval 23.56 to 40.43
|
|
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2
23F
|
115.7 Fold Rise
Interval 77.4 to 172.81
|
32.5 Fold Rise
Interval 21.38 to 49.4
|
6.4 Fold Rise
Interval 4.57 to 8.85
|
130.0 Fold Rise
Interval 94.64 to 178.44
|
SECONDARY outcome
Timeframe: One month after vaccination 1 and One month after vaccination 2/Year 3 to 4Population: Evaluable immunogenicity population; n= number of participants with a determinate IgG concentration to the given serotype.
Antibody geometric mean concentration (GMC) as measured by microgram/milliliter (mcg/mL) for 12 common pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Outcome measures
| Measure |
13vPnC/13vPnC, Cohort 1
n=108 Participants
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 \[Vax2\]) at Year 3 to 4.
|
23vPS/23vPS, Cohort 1
n=407 Participants
Participants aged 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/23vPS, Cohort 1
n=189 Participants
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/13vPnC, Cohort 2
n=211 Participants
Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
|
|---|---|---|---|---|
|
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination
4
|
3.68 mcg/mL
Interval 2.86 to 4.74
|
1.59 mcg/mL
Interval 1.06 to 2.37
|
1.49 mcg/mL
Interval 1.14 to 1.95
|
4.89 mcg/mL
Interval 3.83 to 6.25
|
|
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination
5
|
11.52 mcg/mL
Interval 9.09 to 14.61
|
8.23 mcg/mL
Interval 5.81 to 11.67
|
5.78 mcg/mL
Interval 4.66 to 7.16
|
7.23 mcg/mL
Interval 5.67 to 9.22
|
|
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination
6B
|
11.50 mcg/mL
Interval 9.21 to 14.37
|
7.81 mcg/mL
Interval 5.74 to 10.61
|
5.65 mcg/mL
Interval 4.58 to 6.97
|
19.07 mcg/mL
Interval 14.59 to 24.92
|
|
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination
18C
|
8.56 mcg/mL
Interval 6.77 to 10.84
|
8.21 mcg/mL
Interval 5.64 to 11.96
|
6.30 mcg/mL
Interval 4.7 to 8.45
|
7.17 mcg/mL
Interval 5.68 to 9.03
|
|
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination
19A
|
14.63 mcg/mL
Interval 11.87 to 18.04
|
12.70 mcg/mL
Interval 9.29 to 17.37
|
9.88 mcg/mL
Interval 7.8 to 12.52
|
16.33 mcg/mL
Interval 13.31 to 20.04
|
|
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination
23F
|
7.11 mcg/mL
Interval 5.5 to 9.19
|
4.89 mcg/mL
Interval 3.52 to 6.81
|
3.56 mcg/mL
Interval 2.81 to 4.52
|
17.20 mcg/mL
Interval 13.28 to 22.29
|
|
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination
19F
|
11.51 mcg/mL
Interval 8.64 to 15.34
|
6.42 mcg/mL
Interval 4.11 to 10.01
|
3.44 mcg/mL
Interval 2.5 to 4.73
|
12.89 mcg/mL
Interval 9.75 to 17.06
|
|
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination
1
|
9.53 mcg/mL
Interval 7.53 to 12.07
|
4.13 mcg/mL
Interval 2.86 to 5.96
|
4.36 mcg/mL
Interval 3.33 to 5.72
|
6.92 mcg/mL
Interval 5.31 to 9.03
|
|
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination
3
|
2.58 mcg/mL
Interval 2.14 to 3.11
|
1.88 mcg/mL
Interval 1.29 to 2.74
|
1.81 mcg/mL
Interval 1.44 to 2.29
|
1.33 mcg/mL
Interval 1.07 to 1.64
|
|
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination
7F
|
8.52 mcg/mL
Interval 6.83 to 10.62
|
8.24 mcg/mL
Interval 5.38 to 12.6
|
4.61 mcg/mL
Interval 3.57 to 5.95
|
6.26 mcg/mL
Interval 5.19 to 7.54
|
|
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination
9V
|
7.39 mcg/mL
Interval 5.99 to 9.1
|
5.50 mcg/mL
Interval 4.15 to 7.3
|
3.78 mcg/mL
Interval 3.07 to 4.65
|
4.97 mcg/mL
Interval 4.08 to 6.05
|
|
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination
14
|
16.07 mcg/mL
Interval 12.31 to 20.98
|
12.05 mcg/mL
Interval 7.26 to 19.99
|
8.22 mcg/mL
Interval 6.11 to 11.05
|
14.66 mcg/mL
Interval 11.97 to 17.96
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 14 days after vaccination 2Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group 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 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/13vPnC, Cohort 1
n=80 Participants
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 \[Vax2\]) at Year 3 to 4.
|
23vPS/23vPS, Cohort 1
n=167 Participants
Participants aged 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/23vPS, Cohort 1
n=89 Participants
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/13vPnC, Cohort 2
n=174 Participants
Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Redness: Any
|
20.0 Percentage of participants
Interval 10.0 to 33.7
|
35.8 Percentage of participants
Interval 26.8 to 45.5
|
27.5 Percentage of participants
Interval 15.9 to 41.7
|
21.4 Percentage of participants
Interval 13.2 to 31.7
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Redness: Mild
|
20.0 Percentage of participants
Interval 10.0 to 33.7
|
27.7 Percentage of participants
Interval 19.3 to 37.5
|
22.4 Percentage of participants
Interval 11.8 to 36.6
|
18.1 Percentage of participants
Interval 10.5 to 28.0
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Pain: Mild
|
76.3 Percentage of participants
Interval 65.2 to 85.3
|
80.1 Percentage of participants
Interval 73.0 to 86.1
|
81.9 Percentage of participants
Interval 72.0 to 89.5
|
90.9 Percentage of participants
Interval 85.4 to 94.8
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Limitation of arm movement: Any
|
27.8 Percentage of participants
Interval 16.5 to 41.6
|
48.2 Percentage of participants
Interval 38.7 to 57.9
|
42.1 Percentage of participants
Interval 29.1 to 55.9
|
51.4 Percentage of participants
Interval 41.6 to 61.1
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Limitation of arm movement: Mild
|
24.1 Percentage of participants
Interval 13.5 to 37.6
|
46.4 Percentage of participants
Interval 36.8 to 56.1
|
40.4 Percentage of participants
Interval 27.6 to 54.2
|
48.1 Percentage of participants
Interval 38.3 to 58.0
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Limitation of arm movement:Moderate
|
4.3 Percentage of participants
Interval 0.5 to 14.5
|
3.7 Percentage of participants
Interval 0.8 to 10.4
|
7.0 Percentage of participants
Interval 1.5 to 19.1
|
9.1 Percentage of participants
Interval 3.7 to 17.8
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Limitation of arm movement: Severe
|
2.1 Percentage of participants
Interval 0.1 to 11.3
|
9.5 Percentage of participants
Interval 4.2 to 17.9
|
4.9 Percentage of participants
Interval 0.6 to 16.5
|
5.2 Percentage of participants
Interval 1.4 to 12.8
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Redness: Moderate
|
6.3 Percentage of participants
Interval 1.3 to 17.2
|
18.7 Percentage of participants
Interval 11.3 to 28.2
|
11.4 Percentage of participants
Interval 3.8 to 24.6
|
5.3 Percentage of participants
Interval 1.5 to 13.1
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Redness: Severe
|
0.0 Percentage of participants
Interval 0.0 to 7.5
|
10.6 Percentage of participants
Interval 5.0 to 19.2
|
2.4 Percentage of participants
Interval 0.1 to 12.6
|
1.4 Percentage of participants
Interval 0.0 to 7.4
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Swelling: Any
|
24.5 Percentage of participants
Interval 13.8 to 38.3
|
35.6 Percentage of participants
Interval 26.4 to 45.6
|
20.4 Percentage of participants
Interval 10.2 to 34.3
|
22.6 Percentage of participants
Interval 14.2 to 33.0
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Swelling: Mild
|
21.2 Percentage of participants
Interval 11.1 to 34.7
|
20.9 Percentage of participants
Interval 13.1 to 30.7
|
18.8 Percentage of participants
Interval 8.9 to 32.6
|
21.4 Percentage of participants
Interval 13.2 to 31.7
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Swelling: Moderate
|
10.2 Percentage of participants
Interval 3.4 to 22.2
|
24.2 Percentage of participants
Interval 16.0 to 34.1
|
7.0 Percentage of participants
Interval 1.5 to 19.1
|
4.1 Percentage of participants
Interval 0.9 to 11.5
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Swelling: Severe
|
0.0 Percentage of participants
Interval 0.0 to 7.5
|
7.3 Percentage of participants
Interval 2.7 to 15.2
|
2.4 Percentage of participants
Interval 0.1 to 12.6
|
1.4 Percentage of participants
Interval 0.0 to 7.4
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Pain: Any
|
78.5 Percentage of participants
Interval 67.8 to 86.9
|
84.8 Percentage of participants
Interval 78.3 to 89.9
|
83.9 Percentage of participants
Interval 74.5 to 90.9
|
93.1 Percentage of participants
Interval 88.2 to 96.4
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Pain: Moderate
|
24.5 Percentage of participants
Interval 13.8 to 38.3
|
51.4 Percentage of participants
Interval 41.7 to 61.0
|
44.1 Percentage of participants
Interval 31.2 to 57.6
|
53.6 Percentage of participants
Interval 43.9 to 63.0
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Pain: Severe
|
2.1 Percentage of participants
Interval 0.1 to 11.1
|
11.6 Percentage of participants
Interval 5.7 to 20.3
|
9.1 Percentage of participants
Interval 2.5 to 21.7
|
5.3 Percentage of participants
Interval 1.5 to 13.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 14 days after vaccination 2Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed)=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.
Systemic events reported using an electronic diary. Systemic events are any fever \>=38 degrees C, fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain.
Outcome measures
| Measure |
13vPnC/13vPnC, Cohort 1
n=80 Participants
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 \[Vax2\]) at Year 3 to 4.
|
23vPS/23vPS, Cohort 1
n=162 Participants
Participants aged 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/23vPS, Cohort 1
n=83 Participants
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/13vPnC, Cohort 2
n=167 Participants
Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Fever >= 38 to <38.5 degrees C
|
0.0 Percentage of participants
Interval 0.0 to 7.5
|
2.5 Percentage of participants
Interval 0.3 to 8.8
|
2.4 Percentage of participants
Interval 0.1 to 12.6
|
2.7 Percentage of participants
Interval 0.3 to 9.3
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Fever >=38.5 to <39 degrees C
|
2.1 Percentage of participants
Interval 0.1 to 11.1
|
0.0 Percentage of participants
Interval 0.0 to 4.6
|
2.4 Percentage of participants
Interval 0.1 to 12.6
|
0.0 Percentage of participants
Interval 0.0 to 4.9
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Fever >=39 to =<40 degrees C
|
0.0 Percentage of participants
Interval 0.0 to 7.5
|
0.0 Percentage of participants
Interval 0.0 to 4.6
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
0.0 Percentage of participants
Interval 0.0 to 4.9
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Fever >40 degrees C
|
0.0 Percentage of participants
Interval 0.0 to 7.5
|
0.0 Percentage of participants
Interval 0.0 to 4.6
|
0.0 Percentage of participants
Interval 0.0 to 8.6
|
0.0 Percentage of participants
Interval 0.0 to 4.9
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Fatigue
|
50.7 Percentage of participants
Interval 38.4 to 63.03
|
57.6 Percentage of participants
Interval 48.4 to 66.4
|
63.2 Percentage of participants
Interval 50.7 to 74.6
|
60.8 Percentage of participants
Interval 51.7 to 69.4
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Headache
|
38.3 Percentage of participants
Interval 26.1 to 51.8
|
54.2 Percentage of participants
Interval 44.8 to 63.4
|
50.0 Percentage of participants
Interval 37.2 to 62.8
|
61.8 Percentage of participants
Interval 52.6 to 70.4
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Chills
|
23.1 Percentage of participants
Interval 12.5 to 36.8
|
34.3 Percentage of participants
Interval 25.1 to 44.6
|
33.9 Percentage of participants
Interval 21.8 to 47.8
|
25.8 Percentage of participants
Interval 17.3 to 35.9
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Rash
|
23.5 Percentage of participants
Interval 12.8 to 37.5
|
32.6 Percentage of participants
Interval 23.4 to 43.0
|
18.4 Percentage of participants
Interval 8.8 to 32.0
|
13.6 Percentage of participants
Interval 7.0 to 23.0
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Vomiting
|
8.3 Percentage of participants
Interval 2.3 to 20.0
|
1.3 Percentage of participants
Interval 0.0 to 6.9
|
4.7 Percentage of participants
Interval 0.6 to 15.8
|
3.9 Percentage of participants
Interval 0.8 to 11.1
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Decreased appetite
|
21.2 Percentage of participants
Interval 11.1 to 34.7
|
23.7 Percentage of participants
Interval 15.5 to 33.6
|
31.5 Percentage of participants
Interval 19.5 to 45.6
|
24.7 Percentage of participants
Interval 16.2 to 35.0
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
New generalized muscle pain
|
55.0 Percentage of participants
Interval 41.6 to 67.9
|
67.6 Percentage of participants
Interval 59.1 to 75.4
|
65.2 Percentage of participants
Interval 52.4 to 76.5
|
69.5 Percentage of participants
Interval 60.8 to 77.4
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Aggravated generalized joint pain
|
13.7 Percentage of participants
Interval 5.7 to 26.3
|
17.6 Percentage of participants
Interval 10.4 to 27.0
|
22.4 Percentage of participants
Interval 11.8 to 36.6
|
25.0 Percentage of participants
Interval 16.4 to 35.4
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Aggravated generalized muscle pain
|
27.5 Percentage of participants
Interval 15.9 to 41.7
|
39.6 Percentage of participants
Interval 30.0 to 49.8
|
41.4 Percentage of participants
Interval 28.6 to 55.1
|
34.7 Percentage of participants
Interval 25.3 to 45.2
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
Fever >=38 degrees C
|
2.1 Percentage of participants
Interval 0.1 to 11.1
|
2.5 Percentage of participants
Interval 0.3 to 8.8
|
4.7 Percentage of participants
Interval 0.6 to 15.8
|
2.7 Percentage of participants
Interval 0.3 to 9.3
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 2 (Year 3 to 4) in Cohort 1 and Cohort 2
New generalized joint pain
|
18.9 Percentage of participants
Interval 9.4 to 32.0
|
23.1 Percentage of participants
Interval 14.9 to 33.1
|
24.5 Percentage of participants
Interval 13.8 to 38.3
|
33.3 Percentage of participants
Interval 23.9 to 43.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 14 days after vaccination 1Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed )=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group 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 \[lim\] 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/13vPnC, Cohort 1
n=337 Participants
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 \[Vax2\]) at Year 3 to 4.
|
23vPS/23vPS, Cohort 1
n=307 Participants
Participants aged 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/23vPS, Cohort 1
n=327 Participants
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/13vPnC, Cohort 2
n=801 Participants
Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1
Swelling: Any
|
19.3 Percentage of participants
Interval 14.0 to 25.5
|
13.1 Percentage of participants
Interval 8.7 to 18.7
|
21.7 Percentage of participants
Interval 15.6 to 28.9
|
39.4 Percentage of participants
Interval 33.9 to 45.2
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1
Lim of arm movement:Moderate
|
2.2 Percentage of participants
Interval 0.6 to 5.6
|
3.8 Percentage of participants
Interval 1.6 to 7.8
|
2.9 Percentage of participants
Interval 0.8 to 7.2
|
18.5 Percentage of participants
Interval 13.8 to 24.0
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1
Lim of arm movement:Any
|
28.5 Percentage of participants
Interval 22.6 to 35.1
|
30.8 Percentage of participants
Interval 24.6 to 37.5
|
40.7 Percentage of participants
Interval 33.7 to 48.0
|
75.2 Percentage of participants
Interval 71.1 to 78.9
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1
Redness: Any
|
20.2 Percentage of participants
Interval 14.8 to 26.6
|
14.2 Percentage of participants
Interval 9.6 to 20.0
|
15.8 Percentage of participants
Interval 10.4 to 22.6
|
30.5 Percentage of participants
Interval 25.0 to 36.4
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1
Redness: Mild
|
15.9 Percentage of participants
Interval 11.0 to 21.9
|
11.2 Percentage of participants
Interval 7.1 to 16.7
|
15.2 Percentage of participants
Interval 9.9 to 22.0
|
26.4 Percentage of participants
Interval 21.1 to 32.2
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1
Redness: Moderate
|
8.6 Percentage of participants
Interval 5.0 to 13.7
|
4.9 Percentage of participants
Interval 2.3 to 9.2
|
5.0 Percentage of participants
Interval 2.0 to 10.0
|
11.9 Percentage of participants
Interval 8.0 to 16.8
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1
Redness: Severe
|
1.7 Percentage of participants
Interval 0.3 to 4.8
|
0.0 Percentage of participants
Interval 0.0 to 0.2
|
0.7 Percentage of participants
Interval 0.0 to 4.0
|
2.8 Percentage of participants
Interval 1.1 to 6.1
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1
Swelling: Mild
|
15.6 Percentage of participants
Interval 10.8 to 21.5
|
10.1 Percentage of participants
Interval 6.2 to 15.3
|
20.6 Percentage of participants
Interval 14.6 to 27.7
|
37.2 Percentage of participants
Interval 31.7 to 43.0
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1
Swelling: Moderate
|
8.2 Percentage of participants
Interval 4.6 to 13.1
|
4.4 Percentage of participants
Interval 1.9 to 8.5
|
4.3 Percentage of participants
Interval 1.6 to 9.2
|
15.1 Percentage of participants
Interval 10.8 to 20.3
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1
Swelling: Severe
|
0.6 Percentage of participants
Interval 0.0 to 3.1
|
1.1 Percentage of participants
Interval 0.1 to 4.0
|
0.0 Percentage of participants
Interval 0.0 to 2.7
|
1.4 Percentage of participants
Interval 0.3 to 4.1
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1
Pain: Any
|
80.1 Percentage of participants
Interval 75.3 to 84.2
|
73.4 Percentage of participants
Interval 68.1 to 78.3
|
88.8 Percentage of participants
Interval 84.9 to 92.0
|
96.7 Percentage of participants
Interval 95.2 to 97.8
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1
Pain: Mild
|
78.6 Percentage of participants
Interval 73.8 to 83.0
|
68.6 Percentage of participants
Interval 62.9 to 73.9
|
85.9 Percentage of participants
Interval 81.5 to 89.6
|
93.2 Percentage of participants
Interval 91.1 to 94.4
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1
Pain: Moderate
|
23.3 Percentage of participants
Interval 17.7 to 29.7
|
30.0 Percentage of participants
Interval 23.9 to 36.7
|
39.5 Percentage of participants
Interval 32.5 to 46.8
|
77.1 Percentage of participants
Interval 73.0 to 80.8
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1
Pain: Severe
|
1.7 Percentage of participants
Interval 0.3 to 4.8
|
8.6 Percentage of participants
Interval 5.0 to 13.5
|
3.6 Percentage of participants
Interval 1.2 to 8.2
|
16.0 Percentage of participants
Interval 11.6 to 21.3
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1
Lim of arm movement:Mild
|
26.9 Percentage of participants
Interval 21.0 to 33.4
|
29.3 Percentage of participants
Interval 23.2 to 36.0
|
38.6 Percentage of participants
Interval 31.6 to 46.0
|
71.5 Percentage of participants
Interval 67.1 to 75.5
|
|
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination 1
Lim of arm movement:Severe
|
1.7 Percentage of participants
Interval 0.3 to 4.8
|
4.3 Percentage of participants
Interval 1.9 to 8.3
|
2.9 Percentage of participants
Interval 0.8 to 7.2
|
15.6 Percentage of participants
Interval 11.2 to 20.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 14 days after vaccination 1Population: Safety population included all participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed )=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.
Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (\>=) 38 degrees Celsius \[C\], fatigue, headache, chills, rash, vomiting, decreased appetite, new generalized (gen) muscle pain, aggravated generalized muscle pain , new generalized joint pain), and aggravated generalized joint pain. All reports of fever \>40 degrees C in 13vPnC and 23vPS for Cohort 1 were confirmed as data entry errors.
Outcome measures
| Measure |
13vPnC/13vPnC, Cohort 1
n=327 Participants
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 \[Vax2\]) at Year 3 to 4.
|
23vPS/23vPS, Cohort 1
n=330 Participants
Participants aged 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/23vPS, Cohort 1
n=314 Participants
Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
|
13vPnC/13vPnC, Cohort 2
n=752 Participants
Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
|
|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1
Fever >=38 degrees C
|
7.7 Percentage of participants
Interval 4.3 to 12.6
|
5.9 Percentage of participants
Interval 3.0 to 10.4
|
1.5 Percentage of participants
Interval 0.2 to 5.2
|
7.2 Percentage of participants
Interval 4.2 to 11.5
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1
Fever >=39 to =<40 degrees C
|
0.0 Percentage of participants
Interval 0.0 to 2.1
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
0.0 Percentage of participants
Interval 0.0 to 2.7
|
1.4 Percentage of participants
Interval 0.3 to 4.1
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1
Aggravated gen muscle pain
|
32.6 Percentage of participants
Interval 26.3 to 39.3
|
37.3 Percentage of participants
Interval 31.0 to 44.0
|
39.9 Percentage of participants
Interval 32.8 to 47.3
|
55.9 Percentage of participants
Interval 50.7 to 61.1
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1
Fever >=38 to <38.5 degrees C
|
3.9 Percentage of participants
Interval 1.6 to 7.9
|
1.1 Percentage of participants
Interval 0.1 to 4.0
|
1.5 Percentage of participants
Interval 0.2 to 5.2
|
4.2 Percentage of participants
Interval 1.9 to 7.8
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1
Fever >=38.5 to <39 degrees C
|
0.6 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 2.0
|
0.0 Percentage of participants
Interval 0.0 to 2.7
|
1.9 Percentage of participants
Interval 0.5 to 4.8
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1
Fever >40 degrees C
|
4.4 Percentage of participants
Interval 1.9 to 8.6
|
4.9 Percentage of participants
Interval 2.3 to 9.1
|
0.0 Percentage of participants
Interval 0.0 to 2.7
|
0.5 Percentage of participants
Interval 0.0 to 2.6
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1
Fatigue
|
63.2 Percentage of participants
Interval 57.2 to 68.9
|
61.5 Percentage of participants
Interval 55.5 to 67.3
|
63.3 Percentage of participants
Interval 57.0 to 69.3
|
80.5 Percentage of participants
Interval 77.0 to 83.7
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1
Headache
|
54.0 Percentage of participants
Interval 47.6 to 60.2
|
54.4 Percentage of participants
Interval 48.2 to 60.6
|
65.9 Percentage of participants
Interval 59.6 to 71.8
|
81.4 Percentage of participants
Interval 77.8 to 84.6
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1
Chills
|
23.5 Percentage of participants
Interval 17.9 to 30.0
|
24.1 Percentage of participants
Interval 18.4 to 30.7
|
19.6 Percentage of participants
Interval 13.7 to 26.7
|
38.1 Percentage of participants
Interval 32.5 to 44.0
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1
Rash
|
16.5 Percentage of participants
Interval 11.6 to 22.5
|
13.0 Percentage of participants
Interval 8.6 to 18.6
|
14.2 Percentage of participants
Interval 9.0 to 20.9
|
21.3 Percentage of participants
Interval 16.4 to 26.9
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1
Vomiting
|
3.9 Percentage of participants
Interval 1.6 to 7.8
|
5.4 Percentage of participants
Interval 2.6 to 9.7
|
6.9 Percentage of participants
Interval 3.4 to 12.4
|
15.0 Percentage of participants
Interval 10.7 to 20.2
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1
Decreased appetite
|
21.3 Percentage of participants
Interval 15.9 to 27.6
|
21.7 Percentage of participants
Interval 16.3 to 28.0
|
25.3 Percentage of participants
Interval 18.9 to 32.6
|
55.6 Percentage of participants
Interval 50.4 to 60.8
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1
New gen muscle pain
|
56.2 Percentage of participants
Interval 49.8 to 62.5
|
57.8 Percentage of participants
Interval 51.7 to 63.8
|
61.8 Percentage of participants
Interval 55.3 to 68.0
|
82.0 Percentage of participants
Interval 78.6 to 85.1
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1
New gen joint pain
|
24.4 Percentage of participants
Interval 18.5 to 31.0
|
30.1 Percentage of participants
Interval 24.1 to 36.7
|
31.5 Percentage of participants
Interval 24.5 to 39.2
|
41.7 Percentage of participants
Interval 36.1 to 47.4
|
|
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination 1
Aggravated gen joint pain
|
24.9 Percentage of participants
Interval 19.1 to 31.4
|
21.4 Percentage of participants
Interval 16.0 to 27.6
|
25.6 Percentage of participants
Interval 19.2 to 32.9
|
28.6 Percentage of participants
Interval 23.3 to 34.4
|
Adverse Events
13vPnC, Cohort 1
Serious events: 1 serious events
Other events: 277 other events
Deaths: 0 deaths
13vPnC: 6 Month Follow-up After Vax 1, Cohort 1
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
23vPS, Cohort 1
Serious events: 2 serious events
Other events: 271 other events
Deaths: 0 deaths
23vPS: 6 Month Follow-up After Vax 1, Cohort 1
Serious events: 10 serious events
Other events: 5 other events
Deaths: 0 deaths
13vPnC, Cohort 2
Serious events: 2 serious events
Other events: 293 other events
Deaths: 0 deaths
13vPnC: 6 Month Follow-up After Vax 1, Cohort 2
Serious events: 5 serious events
Other events: 2 other events
Deaths: 0 deaths
13vPnC/13vPnC, Cohort 1
Serious events: 1 serious events
Other events: 66 other events
Deaths: 0 deaths
13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 1
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
13vPnC/23vPS, Cohort 1
Serious events: 1 serious events
Other events: 73 other events
Deaths: 0 deaths
13vPnC/23vPS: 6 Month Follow-up After Vax 2, Cohort 1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
23vPS/23vPS, Cohort 1
Serious events: 0 serious events
Other events: 143 other events
Deaths: 0 deaths
23vPS/23vPS: 6 Month Follow-up After Vax 2, Cohort 1
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
13vPnC/13vPnC, Cohort 2
Serious events: 0 serious events
Other events: 164 other events
Deaths: 0 deaths
13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
13vPnC, Cohort 3
Serious events: 2 serious events
Other events: 779 other events
Deaths: 0 deaths
13vPnC: 6 Month Follow-up After Vax 1, Cohort 3
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC, Cohort 1
n=417 participants at risk
Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1 \[Vax1\]), reported after vaccination.
|
13vPnC: 6 Month Follow-up After Vax 1, Cohort 1
n=417 participants at risk
Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
|
23vPS, Cohort 1
n=414 participants at risk
Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1.
|
23vPS: 6 Month Follow-up After Vax 1, Cohort 1
n=414 participants at risk
Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
|
13vPnC, Cohort 2
n=403 participants at risk
Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant.
|
13vPnC: 6 Month Follow-up After Vax 1, Cohort 2
n=403 participants at risk
Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant.
|
13vPnC/13vPnC, Cohort 1
n=108 participants at risk
Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
|
13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 1
n=108 participants at risk
Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
|
13vPnC/23vPS, Cohort 1
n=108 participants at risk
Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
|
13vPnC/23vPS: 6 Month Follow-up After Vax 2, Cohort 1
n=108 participants at risk
Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
|
23vPS/23vPS, Cohort 1
n=189 participants at risk
Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
|
23vPS/23vPS: 6 Month Follow-up After Vax 2, Cohort 1
n=189 participants at risk
Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
|
13vPnC/13vPnC, Cohort 2
n=214 participants at risk
Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
|
13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 2
n=214 participants at risk
Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
|
13vPnC, Cohort 3
n=899 participants at risk
Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1.
|
13vPnC: 6 Month Follow-up After Vax 1, Cohort 3
n=899 participants at risk
Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer metastatic
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.48%
2/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Depression
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Vascular disorders
Thrombosis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Pyrexia
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Surgical and medical procedures
Lymphadenectomy
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Migraine
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
Other adverse events
| Measure |
13vPnC, Cohort 1
n=417 participants at risk
Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1 \[Vax1\]), reported after vaccination.
|
13vPnC: 6 Month Follow-up After Vax 1, Cohort 1
n=417 participants at risk
Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
|
23vPS, Cohort 1
n=414 participants at risk
Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1.
|
23vPS: 6 Month Follow-up After Vax 1, Cohort 1
n=414 participants at risk
Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
|
13vPnC, Cohort 2
n=403 participants at risk
Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant.
|
13vPnC: 6 Month Follow-up After Vax 1, Cohort 2
n=403 participants at risk
Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant.
|
13vPnC/13vPnC, Cohort 1
n=108 participants at risk
Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
|
13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 1
n=108 participants at risk
Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
|
13vPnC/23vPS, Cohort 1
n=108 participants at risk
Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
|
13vPnC/23vPS: 6 Month Follow-up After Vax 2, Cohort 1
n=108 participants at risk
Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
|
23vPS/23vPS, Cohort 1
n=189 participants at risk
Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
|
23vPS/23vPS: 6 Month Follow-up After Vax 2, Cohort 1
n=189 participants at risk
Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
|
13vPnC/13vPnC, Cohort 2
n=214 participants at risk
Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
|
13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 2
n=214 participants at risk
Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
|
13vPnC, Cohort 3
n=899 participants at risk
Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1.
|
13vPnC: 6 Month Follow-up After Vax 1, Cohort 3
n=899 participants at risk
Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Gingival infection
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Influenza
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.22%
2/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Dizziness
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.33%
3/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Redness (Any)
|
20.2%
39/193 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
14.2%
27/190 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
15.8%
24/152 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
20.0%
10/50 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
27.5%
14/51 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
35.8%
39/109 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
21.4%
18/84 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
30.5%
81/266 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Redness (Mild)
|
15.9%
30/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
11.2%
21/187 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
15.2%
23/151 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
20.0%
10/50 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
22.4%
11/49 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
27.7%
28/101 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
18.1%
15/83 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
26.4%
68/258 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Redness (Moderate)
|
8.6%
16/185 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.9%
9/182 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
5.0%
7/140 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
6.2%
3/48 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
11.4%
5/44 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
18.7%
17/91 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
5.3%
4/75 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
11.9%
27/227 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Redness (Severe)
|
1.7%
3/178 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.73%
1/137 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/47 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.4%
1/42 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
10.6%
9/85 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.4%
1/73 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.8%
6/211 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Swelling (Any)
|
19.3%
38/197 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
13.1%
25/191 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
21.7%
35/161 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
24.5%
13/53 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
20.4%
10/49 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
35.6%
37/104 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
22.6%
19/84 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
39.4%
119/302 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Swelling (Mild)
|
15.6%
30/192 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
10.1%
19/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
20.6%
33/160 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
21.2%
11/52 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
18.8%
9/48 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
20.9%
19/91 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
21.4%
18/84 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
37.2%
109/293 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Swelling (Moderate)
|
8.2%
15/184 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.4%
8/181 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.3%
6/138 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
10.2%
5/49 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
7.0%
3/43 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
24.2%
23/95 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.1%
3/73 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
15.1%
36/238 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Swelling (Severe)
|
0.56%
1/178 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/180 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/136 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/47 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.4%
1/42 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
7.3%
6/82 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.4%
1/73 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.4%
3/209 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Pain (Any)
|
80.1%
265/331 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
73.4%
221/301 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
88.8%
286/322 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
78.5%
62/79 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
83.9%
73/87 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
84.8%
139/164 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
93.1%
161/173 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
96.7%
761/787 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Pain (Mild)
|
78.6%
254/323 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
68.6%
199/290 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
85.9%
263/306 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
76.3%
58/76 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
81.9%
68/83 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
80.1%
125/156 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
90.9%
150/165 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
93.2%
672/721 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Pain (Moderate)
|
23.3%
48/206 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
30.0%
63/210 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
39.5%
75/190 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
24.5%
13/53 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
44.1%
26/59 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
51.4%
57/111 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
53.6%
60/112 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
77.1%
360/467 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Pain (Severe)
|
1.7%
3/178 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
8.6%
16/187 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
3.6%
5/139 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.1%
1/48 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
9.1%
4/44 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
11.6%
10/86 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
5.3%
4/75 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
16.0%
38/238 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Limitation of arm movement (Any)
|
28.5%
61/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
30.8%
65/211 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
40.7%
79/194 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
27.8%
15/54 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
42.1%
24/57 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
48.2%
54/112 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
51.4%
56/109 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
75.2%
375/499 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Limitation of arm movement (Mild)
|
26.9%
57/212 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
29.3%
61/208 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
38.6%
73/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
24.1%
13/54 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
40.4%
23/57 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
46.4%
51/110 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
48.1%
51/106 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
71.5%
333/466 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Limitation of arm movement (Moderate)
|
2.2%
4/179 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
3.8%
7/182 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.9%
4/140 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.3%
2/47 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
7.0%
3/43 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
3.7%
3/81 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
9.1%
7/77 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
18.5%
44/238 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Limitation of arm movement (Severe)
|
1.7%
3/180 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.3%
8/185 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.9%
4/139 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.1%
1/47 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.9%
2/41 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
9.5%
8/84 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
5.2%
4/77 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
15.6%
37/237 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fatigue
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.33%
3/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Headache
|
54.0%
136/252 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
54.4%
141/259 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
65.9%
162/246 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
38.3%
23/60 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
50.0%
32/64 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
54.2%
64/118 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
61.8%
76/123 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
81.4%
429/527 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Chills
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.50%
2/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Rash
|
16.5%
32/194 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
13.0%
25/192 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
14.2%
21/148 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
23.5%
12/51 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
18.4%
9/49 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
32.6%
31/95 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
13.6%
11/81 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
21.3%
53/249 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Vomiting
|
3.9%
7/180 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
5.4%
10/186 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
6.9%
10/144 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
8.3%
4/48 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.7%
2/43 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.3%
1/79 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
3.9%
3/76 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
15.0%
36/240 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Decreased appetite
|
21.3%
43/202 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
21.7%
45/207 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
25.3%
42/166 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
21.2%
11/52 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
31.5%
17/54 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
23.7%
22/93 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
24.7%
22/89 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
55.6%
202/363 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
New generalized muscle pain
|
56.2%
140/249 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
57.8%
155/268 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
61.8%
147/238 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
55.0%
33/60 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
65.2%
43/66 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
67.6%
92/136 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
69.5%
89/128 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
82.0%
460/561 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Aggravated generalized muscle pain
|
32.6%
70/215 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
37.3%
84/225 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
39.9%
75/188 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
27.5%
14/51 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
41.4%
24/58 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
39.6%
40/101 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
34.7%
33/95 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
55.9%
207/370 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
New generalized joint pain
|
24.4%
48/197 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
30.1%
65/216 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
31.5%
52/165 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
18.9%
10/53 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
24.5%
13/53 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
23.1%
21/91 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
33.3%
31/93 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
41.7%
128/307 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Aggravated generalized joint pain
|
24.9%
51/205 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
21.4%
44/206 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
25.6%
43/168 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
13.7%
7/51 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
22.4%
11/49 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
17.6%
16/91 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
25.0%
22/88 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
28.6%
77/269 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Cataract
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Visual impairment
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Oedema peripheral
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Constipation
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Aphonia
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Dementia
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Vascular disorders
Hypertension
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
2/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.22%
2/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
5/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Ear and labyrinth disorders
Ear congestion
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Ear and labyrinth disorders
Vertigo
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Eye irritation
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Eye pruritus
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Vision blurred
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Nausea
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.97%
4/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.50%
2/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.3%
12/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.48%
2/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.48%
2/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.67%
6/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.48%
2/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.22%
2/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.33%
3/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.50%
2/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.50%
2/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Pyrexia
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.48%
2/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site pain
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.48%
2/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site pruritus
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Adverse drug reaction
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Axillary pain
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Influenza like illness
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.22%
2/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site haematoma
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.50%
2/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.22%
2/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site injury
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injury associated with device
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Malaise
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Mass
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site erythema
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site reaction
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site pallor
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site rash
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site swelling
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Sinusitis
|
1.4%
6/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.2%
5/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.99%
4/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.9%
2/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.8%
3/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.96%
4/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.4%
6/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
3.7%
4/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.9%
2/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
3.7%
7/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.4%
3/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.2%
11/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
7/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.50%
2/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.1%
4/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
2/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.78%
7/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Gastroenteritis
|
0.96%
4/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.48%
2/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bronchitis
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.72%
3/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.22%
2/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.72%
3/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.22%
2/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Localised infection
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.48%
2/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.48%
2/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Bacterial infection
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Cellulitis
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.22%
2/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Laryngitis
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Otitis media
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.33%
3/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pneumonia
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Staphylococcal infection
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.50%
2/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.22%
2/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Vaginal infection
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.50%
2/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.22%
2/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Fungal infection
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Hordeolum
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Skin candida
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Tinea infection
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.48%
2/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.48%
2/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Investigations
Prostatic specific antigen increased
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Investigations
Weight decreased
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
5/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.48%
2/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.72%
3/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.50%
2/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.44%
4/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.48%
2/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.74%
3/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.33%
3/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.72%
3/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.22%
2/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.48%
2/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.22%
2/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Headache
|
0.48%
2/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.48%
2/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.33%
3/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Hypoaesthesia
|
0.48%
2/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.48%
2/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.48%
2/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.22%
2/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.22%
2/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.48%
2/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Depressive symptom
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.22%
2/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Reproductive system and breast disorders
Testicular pain
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Reproductive system and breast disorders
Nipple exudate bloody
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.96%
4/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.72%
3/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.4%
3/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.33%
3/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.72%
3/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.48%
2/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.9%
2/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
5/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.44%
4/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmalgia
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.25%
1/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.22%
2/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.48%
2/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.53%
1/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.8%
3/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.56%
5/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.93%
1/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Vascular disorders
Haematoma
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.24%
1/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Vascular disorders
Hot flush
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.47%
1/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Vascular disorders
hypotension
|
0.24%
1/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.50%
2/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fever Any (>=38 degrees C)
|
7.7%
14/181 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
5.9%
11/185 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.5%
2/137 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.1%
1/48 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.7%
2/43 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.5%
2/79 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.7%
2/75 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
7.2%
16/221 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fever Mild (>=38 degrees C but <38.5 degrees C)
|
3.9%
7/179 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.1%
2/180 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.5%
2/137 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/47 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.4%
1/42 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.5%
2/79 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.7%
2/75 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.2%
9/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fever Moderate (>=38.5 degrees C but <39 degrees C)
|
0.56%
1/178 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/136 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.1%
1/48 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
2.4%
1/42 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/78 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/73 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.9%
4/211 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fever Severe (>=39 degrees C but <=40 degrees C)
|
0.00%
0/177 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/179 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/136 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/47 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/41 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/78 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/73 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
1.4%
3/210 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Fever Potentially life threatening (>40 degrees C)
|
4.4%
8/180 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
4.9%
9/184 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/136 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/47 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/41 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/78 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/73 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
—
0/0 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.48%
1/208 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site warmth
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.44%
4/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Pain
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.33%
3/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site irritation
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.22%
2/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
General disorders
Injection site induration
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Immune system disorders
Allergy to vaccine
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.22%
2/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Viral infection
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Investigations
Heart rate increased
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Medial tibial stress syndrome
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Neuritis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Nervous system disorders
Tension headache
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Dermatitis allergic
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Psychiatric disorders
Depression
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/417 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/414 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/403 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/108 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/189 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/214 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.00%
0/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic assessment).
|
0.11%
1/899 • Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.
SAEs and AEs were grouped by system organ class and summarized. AEs included solicited AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and unsolicited events collected on the case report form at each visit (nonsystematic 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