Trial Outcomes & Findings for Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia (NCT NCT01134263)
NCT ID: NCT01134263
Last Updated: 2019-07-24
Results Overview
GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using the plaque reduction neutralization test (PRNT) assay. The lot-to-lot consistency between 3 Phase III lots was based on the use of the two-sided 95% confidence interval (CI) of the differences of the means of the log10 transformed post-vaccination titers between pairs of lots.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
715 participants
Primary outcome timeframe
28 days post-injection 3
Results posted on
2019-07-24
Participant Flow
Study participants were enrolled from 05 October 2010 to 26 November 2010 at 8 study sites in Australia.
A total of 715 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled in the study.
Participant milestones
| Measure |
CYD Dengue Vaccine Phase III Lot 1
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase III Lot 2
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase III Lot 3
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase II Lot
Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
Placebo
Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
164
|
163
|
163
|
168
|
57
|
|
Overall Study
Received Vaccination 1
|
163
|
162
|
163
|
167
|
57
|
|
Overall Study
Received Vaccination 2
|
151
|
152
|
139
|
154
|
53
|
|
Overall Study
Received Vaccination 3
|
140
|
145
|
134
|
151
|
49
|
|
Overall Study
Safety Population
|
163
|
161
|
164
|
167
|
57
|
|
Overall Study
COMPLETED
|
140
|
143
|
134
|
149
|
48
|
|
Overall Study
NOT COMPLETED
|
24
|
20
|
29
|
19
|
9
|
Reasons for withdrawal
| Measure |
CYD Dengue Vaccine Phase III Lot 1
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase III Lot 2
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase III Lot 3
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase II Lot
Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
Placebo
Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
|---|---|---|---|---|---|
|
Overall Study
Serious adverse event
|
2
|
1
|
1
|
1
|
1
|
|
Overall Study
Other adverse event
|
1
|
2
|
5
|
3
|
0
|
|
Overall Study
Protocol Violation
|
8
|
7
|
2
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
5
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
6
|
16
|
7
|
5
|
|
Overall Study
Enrolled, but not treated
|
1
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia
Baseline characteristics by cohort
| Measure |
CYD Dengue Vaccine Phase III Lot 1
n=163 Participants
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase III Lot 2
n=162 Participants
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase III Lot 3
n=163 Participants
Participants received 3 doses of 0.5 ml CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase II Lot
n=167 Participants
Participants received 3 doses of 0.5 ml CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months, subcutaneously.
|
Placebo
n=57 Participants
Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
Total
n=712 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.4 Years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
39.4 Years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
38.7 Years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
38.4 Years
STANDARD_DEVIATION 13.2 • n=4 Participants
|
39.7 Years
STANDARD_DEVIATION 13.5 • n=21 Participants
|
39.0 Years
STANDARD_DEVIATION 13.4 • n=10 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
391 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
321 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 28 days post-injection 3Population: Analysis was performed on Per-protocol analysis set which included participants who received at least 1 dose of the study vaccine or placebo and had no protocol deviations. Data for this outcome measure was not planned to be collected and analyzed for Phase II Lot and placebo.
GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using the plaque reduction neutralization test (PRNT) assay. The lot-to-lot consistency between 3 Phase III lots was based on the use of the two-sided 95% confidence interval (CI) of the differences of the means of the log10 transformed post-vaccination titers between pairs of lots.
Outcome measures
| Measure |
CYD Dengue Vaccine Phase III Lot 1
n=129 Participants
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase III Lot 2
n=123 Participants
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase III Lot 3
n=124 Participants
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month12 (vaccination 3) , subcutaneously.
|
CYD Dengue Vaccine Phase II Lot
Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
Placebo
Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
|---|---|---|---|---|---|
|
Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine
Dengue Virus Serotype 1
|
20.6 Titer (1/dilution)
Interval 16.9 to 25.1
|
18.1 Titer (1/dilution)
Interval 14.8 to 22.2
|
17.1 Titer (1/dilution)
Interval 13.9 to 21.2
|
—
|
—
|
|
Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine
Dengue Virus Serotype 2
|
65.9 Titer (1/dilution)
Interval 50.6 to 85.7
|
44.1 Titer (1/dilution)
Interval 33.3 to 58.3
|
58.1 Titer (1/dilution)
Interval 43.2 to 78.2
|
—
|
—
|
|
Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine
Dengue Virus Serotype 3
|
74.2 Titer (1/dilution)
Interval 60.1 to 91.7
|
65 Titer (1/dilution)
Interval 53.2 to 79.3
|
71.6 Titer (1/dilution)
Interval 58.2 to 88.2
|
—
|
—
|
|
Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine
Dengue Virus Serotype 4
|
131.8 Titer (1/dilution)
Interval 101.4 to 171.3
|
94.6 Titer (1/dilution)
Interval 75.3 to 118.7
|
108.5 Titer (1/dilution)
Interval 84.2 to 139.7
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days post-Injection 3Population: Analysis was performed on Per Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for placebo.
GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using PRNT assay. Equivalence of Phase III vaccine with Phase II vaccine was assessed by Bridging between Phase III and Phase II Lot of CYD Dengue Vaccine.
Outcome measures
| Measure |
CYD Dengue Vaccine Phase III Lot 1
n=376 Participants
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase III Lot 2
n=128 Participants
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase III Lot 3
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month12 (vaccination 3) , subcutaneously.
|
CYD Dengue Vaccine Phase II Lot
Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
Placebo
Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
|---|---|---|---|---|---|
|
Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine
Dengue Virus Serotype 1
|
18.6 Titer (1/dilution)
Interval 16.5 to 20.9
|
15.1 Titer (1/dilution)
Interval 12.4 to 18.4
|
—
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine
Dengue Virus Serotype 2
|
55.4 Titer (1/dilution)
Interval 47.2 to 65.1
|
25.7 Titer (1/dilution)
Interval 20.6 to 32.0
|
—
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine
Dengue Virus Serotype 3
|
70.2 Titer (1/dilution)
Interval 62.4 to 79.1
|
83.6 Titer (1/dilution)
Interval 71.1 to 98.4
|
—
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine
Dengue Virus Serotype 4
|
110.9 Titer (1/dilution)
Interval 96.1 to 127.9
|
115.4 Titer (1/dilution)
Interval 92.8 to 143.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 days post any vaccinationPopulation: Analysis was performed on Safety Analysis Set which included all participants who received the study dose, and participants were analyzed according to the treatment received. Here, 'number analyzed' = participants with available data for each specified category.
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: Significant; prevents daily activity. Erythema and Swelling: Grade 3: \> 10 cm. Participants with Injection Site Reactions of any Grade (1, 2 or 3) and grade 3 were reported.
Outcome measures
| Measure |
CYD Dengue Vaccine Phase III Lot 1
n=163 Participants
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase III Lot 2
n=161 Participants
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase III Lot 3
n=164 Participants
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month12 (vaccination 3) , subcutaneously.
|
CYD Dengue Vaccine Phase II Lot
n=167 Participants
Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
Placebo
n=57 Participants
Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Pain: Any
|
73 Participants
|
74 Participants
|
73 Participants
|
78 Participants
|
11 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Erythema: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Erythema: Any
|
22 Participants
|
15 Participants
|
25 Participants
|
24 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Swelling: Any
|
8 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Pain: Grade 3
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Swelling: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 days post any vaccinationPopulation: Analysis was performed on Safety Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.
Solicited systemic reactions: Asthenia, Fever, Headache, Malaise and Myalgia. Fever: Grade 3: \>=39.0°C (\>=102.1°F). Headache, malaise, myalgia and asthenia: Grade 3: significant; prevents daily activity. Participants with systemic reactions of any Grade (1, 2 or 3) and grade 3 were reported.
Outcome measures
| Measure |
CYD Dengue Vaccine Phase III Lot 1
n=163 Participants
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase III Lot 2
n=161 Participants
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase III Lot 3
n=164 Participants
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month12 (vaccination 3) , subcutaneously.
|
CYD Dengue Vaccine Phase II Lot
n=167 Participants
Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
Placebo
n=57 Participants
Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Asthenia: Grade 3
|
3 Participants
|
9 Participants
|
11 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Malaise: Grade 3
|
10 Participants
|
17 Participants
|
19 Participants
|
13 Participants
|
3 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Asthenia: Any
|
49 Participants
|
51 Participants
|
57 Participants
|
69 Participants
|
20 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Fever: Any
|
5 Participants
|
8 Participants
|
8 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Fever: Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Headache: Any
|
100 Participants
|
96 Participants
|
108 Participants
|
104 Participants
|
28 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Headache: Grade 3
|
8 Participants
|
22 Participants
|
17 Participants
|
14 Participants
|
4 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Malaise: Any
|
72 Participants
|
75 Participants
|
97 Participants
|
90 Participants
|
26 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Myalgia: Any
|
70 Participants
|
69 Participants
|
71 Participants
|
84 Participants
|
21 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Myalgia: Grade 3
|
4 Participants
|
10 Participants
|
11 Participants
|
13 Participants
|
3 Participants
|
Adverse Events
CYD Dengue Vaccine Phase III Lot 1
Serious events: 10 serious events
Other events: 136 other events
Deaths: 0 deaths
CYD Dengue Vaccine Phase III Lot 2
Serious events: 9 serious events
Other events: 131 other events
Deaths: 0 deaths
CYD Dengue Vaccine Phase III Lot 3
Serious events: 5 serious events
Other events: 135 other events
Deaths: 0 deaths
CYD Dengue Vaccine Phase II Lot
Serious events: 9 serious events
Other events: 140 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CYD Dengue Vaccine Phase III Lot 1
n=163 participants at risk
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase III Lot 2
n=161 participants at risk
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase III Lot 3
n=164 participants at risk
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase II Lot
n=167 participants at risk
Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
Placebo
n=57 participants at risk
Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Stress Cardiomyopathy
|
0.61%
1/163 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.62%
1/161 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.61%
1/164 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.61%
1/164 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.61%
1/163 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
General disorders
Chest Pain
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.60%
1/167 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
General disorders
Pyrexia
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.61%
1/164 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.62%
1/161 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.60%
1/167 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.62%
1/161 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.60%
1/167 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Infections and infestations
Bartholin's Abscess
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.62%
1/161 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Infections and infestations
Cellulitis
|
0.61%
1/163 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.62%
1/161 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Infections and infestations
Groin Abscess
|
0.61%
1/163 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
1.8%
1/57 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.60%
1/167 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Foreign Body
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.60%
1/167 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.61%
1/163 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Muscle Rupture
|
0.61%
1/163 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.61%
1/163 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.61%
1/163 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.62%
1/161 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.61%
1/163 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.60%
1/167 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia Rheumatica
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.60%
1/167 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.62%
1/161 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypergammaglobulinaemia Benign Monoclonal
|
0.61%
1/163 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.61%
1/163 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma In Situ
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.62%
1/161 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
1.8%
1/57 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Nervous system disorders
Headache
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.62%
1/161 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.61%
1/164 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.60%
1/167 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.61%
1/164 • Number of events 3 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.62%
1/161 • Number of events 4 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Renal and urinary disorders
Calculus Ureteric
|
0.61%
1/163 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.62%
1/161 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/167 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/163 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/161 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/164 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.60%
1/167 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
Other adverse events
| Measure |
CYD Dengue Vaccine Phase III Lot 1
n=163 participants at risk
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase III Lot 2
n=161 participants at risk
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase III Lot 3
n=164 participants at risk
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
CYD Dengue Vaccine Phase II Lot
n=167 participants at risk
Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
Placebo
n=57 participants at risk
Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Toothache
|
0.61%
1/163 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
1.2%
2/161 • Number of events 3 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
2.4%
4/164 • Number of events 4 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.60%
1/167 • Number of events 4 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
5.3%
3/57 • Number of events 3 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
General disorders
Asthenia
|
30.1%
49/163 • Number of events 66 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
31.7%
51/161 • Number of events 72 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
35.4%
58/164 • Number of events 74 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
41.3%
69/167 • Number of events 90 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
35.1%
20/57 • Number of events 26 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
General disorders
Injection Site Erythema
|
13.5%
22/163 • Number of events 26 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
9.3%
15/161 • Number of events 20 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
15.2%
25/164 • Number of events 31 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
14.4%
24/167 • Number of events 32 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
General disorders
Injection Site Haematoma
|
7.4%
12/163 • Number of events 12 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
5.6%
9/161 • Number of events 11 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
7.3%
12/164 • Number of events 13 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
6.0%
10/167 • Number of events 10 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
10.5%
6/57 • Number of events 6 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
General disorders
Injection Site Pain
|
44.8%
73/163 • Number of events 122 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
46.0%
74/161 • Number of events 114 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
44.5%
73/164 • Number of events 122 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
46.7%
78/167 • Number of events 122 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
19.3%
11/57 • Number of events 15 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
General disorders
Malaise
|
44.2%
72/163 • Number of events 110 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
46.6%
75/161 • Number of events 116 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
59.1%
97/164 • Number of events 146 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
53.9%
90/167 • Number of events 126 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
45.6%
26/57 • Number of events 43 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
General disorders
Pyrexia
|
3.7%
6/163 • Number of events 7 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
5.6%
9/161 • Number of events 11 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
5.5%
9/164 • Number of events 10 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
3.0%
5/167 • Number of events 6 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
1.8%
1/57 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
11/163 • Number of events 13 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
3.7%
6/161 • Number of events 6 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
5.5%
9/164 • Number of events 11 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
4.8%
8/167 • Number of events 8 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
7.0%
4/57 • Number of events 4 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.0%
13/163 • Number of events 13 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
8.7%
14/161 • Number of events 15 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
9.8%
16/164 • Number of events 18 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
8.4%
14/167 • Number of events 15 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
10.5%
6/57 • Number of events 7 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
42.9%
70/163 • Number of events 100 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
42.9%
69/161 • Number of events 105 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
43.9%
72/164 • Number of events 111 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
50.3%
84/167 • Number of events 124 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
36.8%
21/57 • Number of events 30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Nervous system disorders
Headache
|
63.2%
103/163 • Number of events 188 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
60.2%
97/161 • Number of events 186 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
65.9%
108/164 • Number of events 208 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
62.3%
104/167 • Number of events 201 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
49.1%
28/57 • Number of events 61 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
4.3%
7/163 • Number of events 9 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
3.1%
5/161 • Number of events 9 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
1.2%
2/164 • Number of events 2 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
2.4%
4/167 • Number of events 5 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
5.3%
3/57 • Number of events 4 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.5%
9/163 • Number of events 10 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
1.9%
3/161 • Number of events 3 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
1.8%
3/164 • Number of events 3 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
3.6%
6/167 • Number of events 6 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
1.8%
1/57 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
9.8%
16/163 • Number of events 17 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
3.1%
5/161 • Number of events 5 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
4.3%
7/164 • Number of events 7 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
7.2%
12/167 • Number of events 13 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
5.3%
3/57 • Number of events 3 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Analysis was performed on Safety Analysis Set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject 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