Trial Outcomes & Findings for Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity After CYD Tetravalent Dengue Vaccine (NCT NCT01943825)
NCT ID: NCT01943825
Last Updated: 2022-03-24
Results Overview
GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by plaque reduction neutralization test (PRNT). The lower limit of quantitation (LLOQ) of the assay was a titer of 10 (1/dilution).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3
Results posted on
2022-03-24
Participant Flow
Participants were involved in the study from 05 November 2013 to 25 November 2015 in the United States.
A total of 90 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
CYD Dengue Vaccine: Group 1
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
|
CYD Dengue Vaccine: Group 2
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
|
CYD Dengue and Japanese Encephalitis (JE) Vaccine : Group 3
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
|
CYD Dengue and JE Vaccine: Group 4
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
15
|
25
|
25
|
|
Overall Study
COMPLETED
|
15
|
11
|
10
|
14
|
|
Overall Study
NOT COMPLETED
|
10
|
4
|
15
|
11
|
Reasons for withdrawal
| Measure |
CYD Dengue Vaccine: Group 1
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
|
CYD Dengue Vaccine: Group 2
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
|
CYD Dengue and Japanese Encephalitis (JE) Vaccine : Group 3
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
|
CYD Dengue and JE Vaccine: Group 4
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
3
|
12
|
8
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
2
|
|
Overall Study
Other than specified above
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity After CYD Tetravalent Dengue Vaccine
Baseline characteristics by cohort
| Measure |
CYD Dengue Vaccine: Group 1
n=25 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
|
CYD Dengue Vaccine: Group 2
n=15 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
|
CYD Dengue and JE Vaccine : Group 3
n=25 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
|
CYD Dengue and JE Vaccine: Group 4
n=25 Participants
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31.0 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
26.8 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
28.5 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 6.2 • n=4 Participants
|
29.4 years
STANDARD_DEVIATION 6.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3Population: Analysis was performed on full analysis set which included participants who received at least one injection of CYD dengue vaccine or JE vaccine and had at least one blood sample drawn and valid post-injection serology result. Here, 'Number analyzed' = participants with available data for each specified category.
GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by plaque reduction neutralization test (PRNT). The lower limit of quantitation (LLOQ) of the assay was a titer of 10 (1/dilution).
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=25 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
|
CYD Dengue Vaccine: Group 2
n=15 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
|
CYD Dengue and JE Vaccine : Group 3
n=25 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
|
CYD Dengue and JE Vaccine: Group 4
n=25 Participants
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
|
|---|---|---|---|---|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 1: 28 days Post-injection 2
|
8.5 titers (1/dilution)
Interval 5.5 to 13.1
|
6.2 titers (1/dilution)
Interval 4.5 to 8.4
|
10.8 titers (1/dilution)
Interval 5.4 to 21.8
|
10.8 titers (1/dilution)
Interval 6.6 to 17.7
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 2: Pre-injection 2
|
12.1 titers (1/dilution)
Interval 5.3 to 27.4
|
9.6 titers (1/dilution)
Interval 5.8 to 15.9
|
8.8 titers (1/dilution)
Interval 4.8 to 16.1
|
44.5 titers (1/dilution)
Interval 23.1 to 85.7
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 2: 28 days Post-injection 3
|
32.5 titers (1/dilution)
Interval 14.3 to 73.9
|
25.5 titers (1/dilution)
Interval 13.0 to 50.0
|
19.3 titers (1/dilution)
Interval 9.8 to 37.9
|
48.2 titers (1/dilution)
Interval 22.4 to 103.5
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 2: 6 months Post-injection 3
|
13.9 titers (1/dilution)
Interval 6.7 to 29.0
|
7.9 titers (1/dilution)
Interval 4.4 to 14.3
|
10.9 titers (1/dilution)
Interval 4.6 to 26.0
|
21.0 titers (1/dilution)
Interval 9.2 to 48.2
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 3: Pre-injection 1
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
5.2 titers (1/dilution)
Interval 4.8 to 5.6
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 3: 28 days Post-injection 1
|
22.1 titers (1/dilution)
Interval 12.1 to 40.5
|
24.9 titers (1/dilution)
Interval 8.5 to 72.9
|
19.7 titers (1/dilution)
Interval 8.8 to 44.1
|
49.3 titers (1/dilution)
Interval 24.9 to 97.5
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 1: Pre-injection 3
|
7.1 titers (1/dilution)
Interval 4.7 to 10.8
|
6.3 titers (1/dilution)
Interval 4.4 to 9.0
|
8.3 titers (1/dilution)
Interval 4.6 to 15.1
|
6.5 titers (1/dilution)
Interval 4.7 to 9.1
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 1: 28 days Post-injection 3
|
9.1 titers (1/dilution)
Interval 5.5 to 15.0
|
9.9 titers (1/dilution)
Interval 6.0 to 16.6
|
12.0 titers (1/dilution)
Interval 5.4 to 26.7
|
12.9 titers (1/dilution)
Interval 7.6 to 21.9
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 1: Pre-injection 1
|
NA titers (1/dilution)
Participants had a titer reported as less than (\<) LLOQ.
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 1: 28 days Post-injection 1
|
6.1 titers (1/dilution)
Interval 4.8 to 7.8
|
5.5 titers (1/dilution)
Interval 4.5 to 6.8
|
6.8 titers (1/dilution)
Interval 4.7 to 10.0
|
7.4 titers (1/dilution)
Interval 5.3 to 10.2
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 1: Pre-injection 2
|
6.5 titers (1/dilution)
Interval 4.7 to 8.9
|
5.4 titers (1/dilution)
Interval 4.6 to 6.4
|
6.7 titers (1/dilution)
Interval 4.3 to 10.6
|
7.2 titers (1/dilution)
Interval 5.0 to 10.2
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 1: 6 months Post-injection 3
|
5.8 titers (1/dilution)
Interval 4.7 to 7.3
|
6.6 titers (1/dilution)
Interval 4.3 to 9.9
|
8.6 titers (1/dilution)
Interval 3.5 to 21.1
|
7.3 titers (1/dilution)
Interval 5.0 to 10.9
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 2: Pre-injection 1
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 2: 28 days Post-injection 1
|
9.2 titers (1/dilution)
Interval 5.3 to 16.1
|
7.4 titers (1/dilution)
Interval 4.1 to 13.1
|
8.8 titers (1/dilution)
Interval 5.0 to 15.6
|
35.5 titers (1/dilution)
Interval 21.2 to 59.5
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 2: 28 days Post-injection 2
|
19.0 titers (1/dilution)
Interval 8.8 to 41.1
|
10.7 titers (1/dilution)
Interval 5.7 to 19.9
|
17.3 titers (1/dilution)
Interval 7.6 to 39.7
|
61.5 titers (1/dilution)
Interval 30.4 to 124.6
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 2: Pre-injection 3
|
13.3 titers (1/dilution)
Interval 6.7 to 26.4
|
9.8 titers (1/dilution)
Interval 5.1 to 18.8
|
12.2 titers (1/dilution)
Interval 6.7 to 22.2
|
37.4 titers (1/dilution)
Interval 16.1 to 87.1
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 3: Pre-injection 2
|
24.5 titers (1/dilution)
Interval 10.7 to 56.4
|
15.4 titers (1/dilution)
Interval 7.5 to 31.6
|
23.8 titers (1/dilution)
Interval 10.8 to 52.4
|
49.0 titers (1/dilution)
Interval 22.9 to 104.8
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 3: 28 days Post-injection 2
|
31.0 titers (1/dilution)
Interval 15.0 to 63.7
|
40.8 titers (1/dilution)
Interval 14.7 to 113.3
|
28.5 titers (1/dilution)
Interval 12.4 to 65.4
|
68.8 titers (1/dilution)
Interval 36.9 to 128.3
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 3: Pre-injection 3
|
22.9 titers (1/dilution)
Interval 12.1 to 43.2
|
31.7 titers (1/dilution)
Interval 13.9 to 72.0
|
20.5 titers (1/dilution)
Interval 9.5 to 44.1
|
35.6 titers (1/dilution)
Interval 17.8 to 71.6
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 3: 28 days Post-injection 3
|
45.5 titers (1/dilution)
Interval 24.4 to 84.8
|
79.9 titers (1/dilution)
Interval 44.1 to 144.6
|
32.2 titers (1/dilution)
Interval 12.9 to 80.7
|
61.8 titers (1/dilution)
Interval 39.3 to 97.1
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 3: 6 months Post-injection 3
|
19.3 titers (1/dilution)
Interval 10.2 to 36.6
|
33.9 titers (1/dilution)
Interval 13.9 to 82.5
|
19.3 titers (1/dilution)
Interval 7.5 to 49.5
|
24.8 titers (1/dilution)
Interval 12.6 to 48.7
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 4: Pre-injection 1
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 4: 28 days Post-injection 1
|
425.8 titers (1/dilution)
Interval 172.1 to 1053.4
|
669.7 titers (1/dilution)
Interval 188.3 to 2381.8
|
177.6 titers (1/dilution)
Interval 62.1 to 508.1
|
325.4 titers (1/dilution)
Interval 147.8 to 716.3
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 4: Pre-injection 2
|
296.2 titers (1/dilution)
Interval 151.9 to 577.6
|
100.3 titers (1/dilution)
Interval 51.7 to 194.6
|
89.9 titers (1/dilution)
Interval 24.8 to 326.2
|
300.9 titers (1/dilution)
Interval 144.4 to 627.0
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 4: 28 days Post-injection 2
|
166.6 titers (1/dilution)
Interval 90.2 to 307.7
|
147.1 titers (1/dilution)
Interval 91.8 to 235.7
|
68.0 titers (1/dilution)
Interval 23.4 to 197.1
|
211.3 titers (1/dilution)
Interval 103.3 to 432.2
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 4: Pre-injection 3
|
108.9 titers (1/dilution)
Interval 63.5 to 186.6
|
89.8 titers (1/dilution)
Interval 49.2 to 163.9
|
47.7 titers (1/dilution)
Interval 18.4 to 123.9
|
139.5 titers (1/dilution)
Interval 65.8 to 295.4
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 4: 28 days Post-injection 3
|
120.4 titers (1/dilution)
Interval 67.2 to 215.7
|
124.5 titers (1/dilution)
Interval 78.2 to 198.1
|
55.4 titers (1/dilution)
Interval 22.5 to 136.8
|
152.5 titers (1/dilution)
Interval 75.3 to 308.6
|
|
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 4: 6 months Post-injection 3
|
105.3 titers (1/dilution)
Interval 52.5 to 211.1
|
106.7 titers (1/dilution)
Interval 71.7 to 158.8
|
43.8 titers (1/dilution)
Interval 13.3 to 144.3
|
92.6 titers (1/dilution)
Interval 56.7 to 151.1
|
PRIMARY outcome
Timeframe: Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3Population: Analysis was performed on full analysis set. Here, 'Number analyzed' = participants with available data for each specified category.
Antibody titers against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT.
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=25 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
|
CYD Dengue Vaccine: Group 2
n=15 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
|
CYD Dengue and JE Vaccine : Group 3
n=25 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
|
CYD Dengue and JE Vaccine: Group 4
n=25 Participants
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
|
|---|---|---|---|---|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 1: Pre-injection 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 1: 28 days Post-injection 1
|
3 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 1: Pre-injection 2
|
3 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 1: 28 days Post-injection 2
|
6 Participants
|
2 Participants
|
5 Participants
|
8 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 1: Pre-injection 3
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 1: 28 days Post-injection 3
|
5 Participants
|
6 Participants
|
5 Participants
|
9 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 1: 6 months Post-injection 3
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 2: Pre-injection 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 2: 28 days Post-injection 1
|
5 Participants
|
2 Participants
|
4 Participants
|
16 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 2: Pre-injection 2
|
5 Participants
|
7 Participants
|
4 Participants
|
15 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 2: 28 days Post-injection 2
|
9 Participants
|
5 Participants
|
7 Participants
|
16 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 3: 28 days Post-injection 2
|
12 Participants
|
9 Participants
|
10 Participants
|
16 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 3: Pre-injection 3
|
12 Participants
|
10 Participants
|
9 Participants
|
12 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 3: 28 days Post-injection 3
|
14 Participants
|
12 Participants
|
9 Participants
|
16 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 3: 6 months Post-injection 3
|
10 Participants
|
9 Participants
|
6 Participants
|
10 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 4: Pre-injection 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 4: 28 days Post-injection 1
|
21 Participants
|
13 Participants
|
16 Participants
|
18 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 4: Pre-injection 2
|
21 Participants
|
13 Participants
|
11 Participants
|
18 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 4: 28 days Post-injection 2
|
17 Participants
|
13 Participants
|
11 Participants
|
18 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 4: Pre-injection 3
|
17 Participants
|
12 Participants
|
11 Participants
|
16 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 4: 28 days Post-injection 3
|
16 Participants
|
12 Participants
|
11 Participants
|
16 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 4: 6 months Post-injection 3
|
15 Participants
|
11 Participants
|
7 Participants
|
14 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 2: Pre-injection 3
|
8 Participants
|
4 Participants
|
7 Participants
|
13 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 2: 28 days Post-injection 3
|
12 Participants
|
9 Participants
|
9 Participants
|
15 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 2: 6 months Post-injection 3
|
7 Participants
|
3 Participants
|
4 Participants
|
9 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 3: Pre-injection 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 3: 28 days Post-injection 1
|
15 Participants
|
7 Participants
|
10 Participants
|
16 Participants
|
|
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Serotype 3: Pre-injection 2
|
11 Participants
|
7 Participants
|
10 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Pre-injection 1, 2 and 3, and 28 days post-injection 1, 2 and 3Population: Analysis was performed on full analysis set. Here, 'Number analyzed' = participants with available data for each specified category.
GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT. The LLOQ of the assay was a titer of 10 (1/dilution).
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=25 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
|
CYD Dengue Vaccine: Group 2
n=25 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
|
CYD Dengue and JE Vaccine : Group 3
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
|
CYD Dengue and JE Vaccine: Group 4
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
|
|---|---|---|---|---|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 4: 28 days Post-injection 2
|
68.0 titers (1/dilution)
Interval 23.4 to 197.1
|
211.3 titers (1/dilution)
Interval 103.3 to 432.2
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 1: Pre-injection 1
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 1: 28 days Post-injection 1
|
6.8 titers (1/dilution)
Interval 4.7 to 10.0
|
7.4 titers (1/dilution)
Interval 5.3 to 10.2
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 1: Pre-injection 2
|
6.7 titers (1/dilution)
Interval 4.3 to 10.6
|
7.2 titers (1/dilution)
Interval 5.0 to 10.2
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 1: 28 days Post-injection 2
|
10.8 titers (1/dilution)
Interval 5.4 to 21.8
|
10.8 titers (1/dilution)
Interval 6.6 to 17.7
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 1: Pre-injection 3
|
8.3 titers (1/dilution)
Interval 4.6 to 15.1
|
6.5 titers (1/dilution)
Interval 4.7 to 9.1
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 1: 28 days Post-injection 3
|
12.0 titers (1/dilution)
Interval 5.4 to 26.7
|
12.9 titers (1/dilution)
Interval 7.6 to 21.9
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 2: Pre-injection 1
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 2: 28 days Post-injection 1
|
8.8 titers (1/dilution)
Interval 5.0 to 15.6
|
35.5 titers (1/dilution)
Interval 21.2 to 59.5
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 2: Pre-injection 2
|
8.8 titers (1/dilution)
Interval 4.8 to 16.1
|
44.5 titers (1/dilution)
Interval 23.1 to 85.7
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 2: 28 days Post-injection 2
|
17.3 titers (1/dilution)
Interval 7.6 to 39.7
|
61.5 titers (1/dilution)
Interval 30.4 to 124.6
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 2: Pre-injection 3
|
12.2 titers (1/dilution)
Interval 6.7 to 22.2
|
37.4 titers (1/dilution)
Interval 16.1 to 87.1
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 2: 28 days Post-injection 3
|
19.3 titers (1/dilution)
Interval 9.8 to 37.9
|
48.2 titers (1/dilution)
Interval 22.4 to 103.5
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 3: Pre-injection 1
|
5.2 titers (1/dilution)
Interval 4.8 to 5.6
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 3: 28 days Post-injection 1
|
19.7 titers (1/dilution)
Interval 8.8 to 44.1
|
49.3 titers (1/dilution)
Interval 24.9 to 97.5
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 3: Pre-injection 2
|
23.8 titers (1/dilution)
Interval 10.8 to 52.4
|
49.0 titers (1/dilution)
Interval 22.9 to 104.8
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 3: 28 days Post-injection 2
|
28.5 titers (1/dilution)
Interval 12.4 to 65.4
|
68.8 titers (1/dilution)
Interval 36.9 to 128.3
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 3: Pre-injection 3
|
20.5 titers (1/dilution)
Interval 9.5 to 44.1
|
35.6 titers (1/dilution)
Interval 17.8 to 71.6
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 3: 28 days Post-injection 3
|
32.2 titers (1/dilution)
Interval 12.9 to 80.7
|
61.8 titers (1/dilution)
Interval 39.3 to 97.1
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 4: Pre-injection 1
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 4: 28 days Post-injection 1
|
177.6 titers (1/dilution)
Interval 62.1 to 508.1
|
325.4 titers (1/dilution)
Interval 147.8 to 716.3
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 4: Pre-injection 2
|
89.9 titers (1/dilution)
Interval 24.8 to 326.2
|
300.9 titers (1/dilution)
Interval 144.4 to 627.0
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 4: Pre-injection 3
|
47.7 titers (1/dilution)
Interval 18.4 to 123.9
|
139.5 titers (1/dilution)
Interval 65.8 to 295.4
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Serotype 4: 28 days Post-injection 3
|
55.4 titers (1/dilution)
Interval 22.5 to 136.8
|
152.5 titers (1/dilution)
Interval 75.3 to 308.6
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months and 12 months post-injection 3Population: Analysis was performed on full analysis set. Here, 'Number analyzed' = participants with available data for each specified category. Data was not planned to be collected and analyzed for Groups 2 and 4 for 12 months post-injection 3 time point.
GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT.
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=25 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
|
CYD Dengue Vaccine: Group 2
n=15 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
|
CYD Dengue and JE Vaccine : Group 3
n=25 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
|
CYD Dengue and JE Vaccine: Group 4
n=25 Participants
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
|
|---|---|---|---|---|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 1: 6 months Post-injection 3
|
5.8 titers (1/dilution)
Interval 4.7 to 7.3
|
6.6 titers (1/dilution)
Interval 4.3 to 9.9
|
8.6 titers (1/dilution)
Interval 3.5 to 12.1
|
7.3 titers (1/dilution)
Interval 5.0 to 10.9
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 2: 6 months Post-injection 3
|
13.9 titers (1/dilution)
Interval 6.7 to 29.0
|
7.9 titers (1/dilution)
Interval 4.4 to 14.3
|
10.9 titers (1/dilution)
Interval 4.6 to 26.0
|
21.0 titers (1/dilution)
Interval 9.2 to 48.2
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 3: 6 months Post-injection 3
|
19.3 titers (1/dilution)
Interval 10.2 to 36.6
|
33.9 titers (1/dilution)
Interval 13.9 to 82.5
|
19.3 titers (1/dilution)
Interval 7.5 to 49.5
|
24.8 titers (1/dilution)
Interval 12.6 to 48.7
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 4: 6 months Post-injection 3
|
105.3 titers (1/dilution)
Interval 52.5 to 211.1
|
106.7 titers (1/dilution)
Interval 71.7 to 158.8
|
43.8 titers (1/dilution)
Interval 13.3 to 144.3
|
92.6 titers (1/dilution)
Interval 56.7 to 151.1
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 1: 12 months Post-injection 3
|
5.3 titers (1/dilution)
Interval 4.7 to 6.0
|
—
|
7.8 titers (1/dilution)
Interval 4.2 to 14.5
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 2: 12 months Post-injection 3
|
11.5 titers (1/dilution)
Interval 5.2 to 25.5
|
—
|
7.6 titers (1/dilution)
Interval 3.7 to 15.6
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 3: 12 months Post-injection 3
|
18.3 titers (1/dilution)
Interval 9.5 to 35.2
|
—
|
16.2 titers (1/dilution)
Interval 5.8 to 45.0
|
—
|
|
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains
Serotype 4: 12 months Post-injection 3
|
144.8 titers (1/dilution)
Interval 68.8 to 304.8
|
—
|
23.9 titers (1/dilution)
Interval 8.1 to 70.8
|
—
|
SECONDARY outcome
Timeframe: 3, 5, 7 and 14 days post-injection 1, 2 and 3Population: Analysis was performed on full analysis set. Here, 'Number analyzed' = participants with available data for each specified category.
Viremia was determined by reverse transcriptase (RT) polymerase chain reaction (PCR) using primer/probes specific to a non serotype-specific part of the dengue vaccine.
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=25 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
|
CYD Dengue Vaccine: Group 2
n=15 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
|
CYD Dengue and JE Vaccine : Group 3
n=25 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
|
CYD Dengue and JE Vaccine: Group 4
n=25 Participants
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
|
|---|---|---|---|---|
|
Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia
3 days Post-Injection 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia
5 days Post-Injection 1
|
7 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia
7 days Post-Injection 1
|
16 Participants
|
9 Participants
|
8 Participants
|
9 Participants
|
|
Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia
14 days Post-Injection 1
|
12 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia
3 days Post-Injection 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia
5 days Post-Injection 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia
7 days Post-Injection 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia
14 days Post-Injection 2
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia
3 days Post-Injection 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia
5 days Post-Injection 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia
7 days Post-Injection 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia
14 days Post-Injection 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3, 5, 7 and 14 days post-injection 1; 3 and 14 days post-injection 2 and 7 days post-injection 3Population: Analysis was performed on full analysis set. Here, 'Number analyzed' = participants with available data for each specified category.
Viremia was determined by RT PCR using primer/probes specific to each dengue vaccine serotypes.
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=25 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
|
CYD Dengue Vaccine: Group 2
n=15 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
|
CYD Dengue and JE Vaccine : Group 3
n=25 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
|
CYD Dengue and JE Vaccine: Group 4
n=25 Participants
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
|
|---|---|---|---|---|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 1: 3 days Post-Injection 1
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 1: 5 days Post-Injection 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 1: 7 days Post-Injection 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 1: 14 days Post-Injection 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 1: 3 days Post-Injection 2
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 1: 14 days Post-Injection 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 1: 7 days Post-Injection 3
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 2: 3 days Post-Injection 1
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 2: 5 days Post-Injection 1
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 2: 7 days Post-Injection 1
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 2: 14 days Post-Injection 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 2: 3 days Post-Injection 2
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 2: 14 days Post-Injection 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 2: 7 days Post-Injection 3
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 3: 3 days Post-Injection 1
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 3: 5 days Post-Injection 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 3: 7 days Post-Injection 1
|
5 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 3: 14 days Post-Injection 1
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 3: 3 days Post-Injection 2
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 3: 14 days Post-Injection 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 3: 7 days Post-Injection 3
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 4: 3 days Post-Injection 1
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 4: 5 days Post-Injection 1
|
6 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 4: 7 days Post-Injection 1
|
13 Participants
|
7 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 4: 14 days Post-Injection 1
|
8 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 4: 3 days Post-Injection 2
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 4: 14 days Post-Injection 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Serotype 4: 7 days Post-Injection 3
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-injection 1, and 28 days post-injection 1, 2 and 3Population: Analysis was performed on full analysis set. Here, 'Number analyzed' = participants with available data for each specified category.
GMTs of antibodies against JE were measured by JE micro neutralization assay. The LLOQ of the assay was a titer of 10 (1/dilution).
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=25 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
|
CYD Dengue Vaccine: Group 2
n=25 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
|
CYD Dengue and JE Vaccine : Group 3
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
|
CYD Dengue and JE Vaccine: Group 4
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
|
|---|---|---|---|---|
|
Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4
Pre-injection 1
|
NA titers (1/dilution)
Participants had a titer reported as \< LLOQ.
|
22.9 titers (1/dilution)
Interval 12.7 to 41.0
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4
28 days Post-injection 1
|
132.3 titers (1/dilution)
Interval 48.4 to 361.9
|
620.9 titers (1/dilution)
Interval 337.5 to 1142.3
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4
28 days Post-injection 2
|
382.7 titers (1/dilution)
Interval 134.7 to 1087.9
|
501.8 titers (1/dilution)
Interval 253.0 to 995.5
|
—
|
—
|
|
Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4
28 days Post-injection 3
|
82.3 titers (1/dilution)
Interval 40.3 to 167.9
|
157.4 titers (1/dilution)
Interval 74.9 to 330.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 7 days after any CYD dengue vaccine and/or JE vaccinePopulation: Analysis was performed on safety analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the electronic case report form (eCRF) and considered as related to vaccination. Solicited injection site reactions: pain, erythema, and swelling.
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=24 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
|
CYD Dengue Vaccine: Group 2
n=15 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
|
CYD Dengue and JE Vaccine : Group 3
n=22 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
|
CYD Dengue and JE Vaccine: Group 4
n=19 Participants
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Injection Site Reactions
Injection site Pain
|
7 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Injection site Erythema
|
7 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Injection site Swelling
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within 14 days after any CYD dengue vaccine and/or JE vaccinePopulation: Analysis was performed on safety analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited systemic reactions: fever, headache, malaise, myalgia, and asthenia.
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=24 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
|
CYD Dengue Vaccine: Group 2
n=15 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
|
CYD Dengue and JE Vaccine : Group 3
n=22 Participants
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
|
CYD Dengue and JE Vaccine: Group 4
n=19 Participants
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
|
|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Reactions
Fever
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Headache
|
10 Participants
|
11 Participants
|
12 Participants
|
11 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Malaise
|
9 Participants
|
10 Participants
|
11 Participants
|
6 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Myalgia
|
8 Participants
|
6 Participants
|
10 Participants
|
7 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Asthenia
|
6 Participants
|
7 Participants
|
7 Participants
|
3 Participants
|
Adverse Events
CYD Dengue Vaccine: Group 1
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
CYD Dengue Vaccine: Group 2
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
CYD Dengue and JE Vaccine : Group 3
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
CYD Dengue and JE Vaccine: Group 4
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CYD Dengue Vaccine: Group 1
n=25 participants at risk
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
|
CYD Dengue Vaccine: Group 2
n=15 participants at risk
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
|
CYD Dengue and JE Vaccine : Group 3
n=25 participants at risk
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
|
CYD Dengue and JE Vaccine: Group 4
n=25 participants at risk
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/15 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Cellulitis
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/15 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/15 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Drug dependence
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/15 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
Other adverse events
| Measure |
CYD Dengue Vaccine: Group 1
n=25 participants at risk
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
|
CYD Dengue Vaccine: Group 2
n=15 participants at risk
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
|
CYD Dengue and JE Vaccine : Group 3
n=25 participants at risk
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
|
CYD Dengue and JE Vaccine: Group 4
n=25 participants at risk
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/15 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
8.0%
2/25 • Number of events 4 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Nausea
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
3/25 • Number of events 3 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Asthenia
|
24.0%
6/25 • Number of events 12 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
46.7%
7/15 • Number of events 11 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
28.0%
7/25 • Number of events 13 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
32.0%
8/25 • Number of events 14 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Fatigue
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
13.3%
2/15 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Injection site erythema
|
28.0%
7/25 • Number of events 11 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
26.7%
4/15 • Number of events 6 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Injection site pain
|
28.0%
7/25 • Number of events 8 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
40.0%
6/15 • Number of events 8 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
32.0%
8/25 • Number of events 13 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
52.0%
13/25 • Number of events 25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Injection site pruritus
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Injection site swelling
|
12.0%
3/25 • Number of events 3 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
13.3%
2/15 • Number of events 3 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Injection site warmth
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Malaise
|
36.0%
9/25 • Number of events 16 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
66.7%
10/15 • Number of events 12 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
44.0%
11/25 • Number of events 22 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
44.0%
11/25 • Number of events 23 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Pyrexia
|
8.0%
2/25 • Number of events 3 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
13.3%
2/15 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
12.0%
3/25 • Number of events 3 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
8.0%
2/25 • Number of events 3 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Influenza
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/15 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Lice infestation
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Nasopharyngitis
|
16.0%
4/25 • Number of events 7 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
13.3%
2/15 • Number of events 3 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
24.0%
6/25 • Number of events 7 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Oral infection
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/15 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Sinusitis
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
12.0%
3/25 • Number of events 3 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Trichomoniasis
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
28.0%
7/25 • Number of events 7 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
46.7%
7/15 • Number of events 7 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
12.0%
3/25 • Number of events 3 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
28.0%
7/25 • Number of events 7 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
20.0%
3/15 • Number of events 5 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/15 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.0%
1/25 • Number of events 3 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Investigations
Heart rate decreased
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Investigations
Heart rate increased
|
12.0%
3/25 • Number of events 3 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
12.0%
3/25 • Number of events 3 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Bunion
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Enostosis
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
36.0%
9/25 • Number of events 14 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
40.0%
6/15 • Number of events 11 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
40.0%
10/25 • Number of events 22 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
40.0%
10/25 • Number of events 22 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Headache
|
36.0%
9/25 • Number of events 27 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
86.7%
13/15 • Number of events 22 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
48.0%
12/25 • Number of events 37 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
56.0%
14/25 • Number of events 46 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Migraine
|
8.0%
2/25 • Number of events 5 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/15 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Vomiting in pregnancy
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Insomnia
|
8.0%
2/25 • Number of events 3 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
13.3%
2/15 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
13.3%
2/15 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
12.0%
3/25 • Number of events 3 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
12.0%
3/25 • Number of events 7 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/15 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.0%
1/25 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
13.3%
2/15 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
8.0%
2/25 • Number of events 3 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/15 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
8.0%
2/25 • Number of events 5 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Hypertension
|
8.0%
2/25 • Number of events 2 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/15 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.0%
1/25 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Hypotension
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
1/15 • Number of events 1 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/25 • Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
- Publication restrictions are in place
Restriction type: OTHER