Trial Outcomes & Findings for Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Given With or Without Yellow Fever Vaccine (NCT NCT01488890)
NCT ID: NCT01488890
Last Updated: 2022-03-24
Results Overview
GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test (PRNT).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
390 participants
Primary outcome timeframe
Pre-injection 1, 28 days and 6 months post-injection 3
Results posted on
2022-03-24
Participant Flow
Study participants were enrolled from 06 December 2011 to 22 March 2012 in the United States.
A total of 390 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
CYD Dengue Vaccine: Group 1
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
|
CYD Dengue Vaccine: Group 2
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
|
CYD Dengue and Yellow Fever (YF) Vaccine: Group 3
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
|
Yellow Fever Vaccine: Group 4
Participants received single dose of YF vaccine at Day 0.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
120
|
120
|
120
|
30
|
|
Overall Study
Treated
|
120
|
120
|
119
|
30
|
|
Overall Study
COMPLETED
|
88
|
100
|
85
|
25
|
|
Overall Study
NOT COMPLETED
|
32
|
20
|
35
|
5
|
Reasons for withdrawal
| Measure |
CYD Dengue Vaccine: Group 1
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
|
CYD Dengue Vaccine: Group 2
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
|
CYD Dengue and Yellow Fever (YF) Vaccine: Group 3
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
|
Yellow Fever Vaccine: Group 4
Participants received single dose of YF vaccine at Day 0.
|
|---|---|---|---|---|
|
Overall Study
Serious adverse event
|
2
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
3
|
0
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
13
|
10
|
20
|
3
|
|
Overall Study
Withdrawal by Subject
|
14
|
10
|
11
|
2
|
Baseline Characteristics
Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Given With or Without Yellow Fever Vaccine
Baseline characteristics by cohort
| Measure |
CYD Dengue Vaccine: Group 1
n=120 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
|
CYD Dengue Vaccine: Group 2
n=120 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
|
CYD Dengue and Yellow Fever Vaccine: Group 3
n=120 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
|
Yellow Fever Vaccine: Group 4
n=30 Participants
Participants received single dose of YF vaccine at Day 0.
|
Total
n=390 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
120 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
390 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
31.6 Years
STANDARD_DEVIATION 7.63 • n=5 Participants
|
32.6 Years
STANDARD_DEVIATION 7.32 • n=7 Participants
|
32.6 Years
STANDARD_DEVIATION 7.52 • n=5 Participants
|
34.8 Years
STANDARD_DEVIATION 8.63 • n=4 Participants
|
32.5 Years
STANDARD_DEVIATION 7.59 • n=21 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
195 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
195 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-injection 1, 28 days and 6 months post-injection 3Population: Full Analysis Set included participants who received at least 1 Inj. of CYD dengue or/ YF vaccine, had at least 1 blood sample drawn and valid post-Inj. serology result. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 3 and 4.
GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test (PRNT).
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=117 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
|
CYD Dengue Vaccine: Group 2
n=119 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
|
CYD Dengue and Yellow Fever Vaccine: Group 3
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
|
Yellow Fever Vaccine: Group 4
Participants received single dose of YF vaccine at Day 0.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 1: Pre-injection 1
|
5.38 Titers (1/dilution)
Interval 4.85 to 5.96
|
5.13 Titers (1/dilution)
Interval 4.98 to 5.28
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 1: 28 days Post-injection 3
|
14.8 Titers (1/dilution)
Interval 11.3 to 19.4
|
15.9 Titers (1/dilution)
Interval 12.6 to 20.0
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 1: 6 months Post-injection 3
|
13.3 Titers (1/dilution)
Interval 10.2 to 17.4
|
9.01 Titers (1/dilution)
Interval 7.54 to 10.8
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 2: Pre-injection 1
|
5.19 Titers (1/dilution)
Interval 4.82 to 5.58
|
5.22 Titers (1/dilution)
Interval 4.96 to 5.5
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 2: 28 days Post-injection 3
|
51.2 Titers (1/dilution)
Interval 38.2 to 68.6
|
59.9 Titers (1/dilution)
Interval 45.8 to 78.4
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 2: 6 months Post-injection 3
|
45.6 Titers (1/dilution)
Interval 31.6 to 65.6
|
38.7 Titers (1/dilution)
Interval 29.5 to 50.8
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 3: Pre-injection
|
5.32 Titers (1/dilution)
Interval 4.94 to 5.73
|
5.28 Titers (1/dilution)
Interval 5.03 to 5.55
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 3: 28 days Post-injection 3
|
45.7 Titers (1/dilution)
Interval 35.0 to 59.8
|
59.3 Titers (1/dilution)
Interval 47.0 to 74.7
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 3: 6 months Post-injection 3
|
30.2 Titers (1/dilution)
Interval 22.8 to 40.2
|
34.5 Titers (1/dilution)
Interval 27.5 to 43.3
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 4: Pre-injection 1
|
5.78 Titers (1/dilution)
Interval 5.16 to 6.48
|
5.11 Titers (1/dilution)
Interval 4.9 to 5.33
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 4: Post-injection 3
|
66.8 Titers (1/dilution)
Interval 50.9 to 87.8
|
83.1 Titers (1/dilution)
Interval 61.4 to 112.0
|
—
|
—
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 4: 6 months Post-injection 3
|
74.8 Titers (1/dilution)
Interval 54.9 to 102.0
|
41.7 Titers (1/dilution)
Interval 31.2 to 55.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-injection 1, 28 days and 6 months post-injection 3Population: Analysis was performed on Full Analysis Set. Here, 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 3 and 4.
Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer \>=10 (1/dilution).
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=117 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
|
CYD Dengue Vaccine: Group 2
n=119 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
|
CYD Dengue and Yellow Fever Vaccine: Group 3
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
|
Yellow Fever Vaccine: Group 4
Participants received single dose of YF vaccine at Day 0.
|
|---|---|---|---|---|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 1: Pre-injection 1
|
1.7 percentage of participants
|
2.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 1: 28 days Post-injection 3
|
52.7 percentage of participants
|
56.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 1: 6 months Post-injection 3
|
47.7 percentage of participants
|
32.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 2: Pre-injection 1
|
0.9 percentage of participants
|
2.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 2: 28 days Post-injection 3
|
84.0 percentage of participants
|
88.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 2: 6 months Post-injection 3
|
75.0 percentage of participants
|
80.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 3: Pre-injection 1
|
2.6 percentage of participants
|
4.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 3: 28 days Post-injection 3
|
85.1 percentage of participants
|
90.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 3: 6 months Post-injection 3
|
79.5 percentage of participants
|
80.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 4: Pre-injection 1
|
6.8 percentage of participants
|
0.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 4: 28 days Post-injection 3
|
88.3 percentage of participants
|
86.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Dengue Virus Serotype 4: 6 months Post-injection 3
|
86.4 percentage of participants
|
74.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-injection 1 and 2 and 28 days post-injection 1 and 2Population: Analysis was performed on Full 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 Group 3 and 4.
GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT.
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=117 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
|
CYD Dengue Vaccine: Group 2
n=119 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
|
CYD Dengue and Yellow Fever Vaccine: Group 3
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
|
Yellow Fever Vaccine: Group 4
Participants received single dose of YF vaccine at Day 0.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 1: Pre-injection 1
|
5.38 Titer (1/dilution)
Interval 4.85 to 5.96
|
5.13 Titer (1/dilution)
Interval 4.98 to 5.28
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 1: 28 days Post-injection 1
|
10.3 Titer (1/dilution)
Interval 8.15 to 13.1
|
8.75 Titer (1/dilution)
Interval 7.19 to 10.6
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 1: Pre-injection 2
|
11.2 Titer (1/dilution)
Interval 8.76 to 14.4
|
11.5 Titer (1/dilution)
Interval 9.17 to 14.4
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 1: 28 days Post-injection 2
|
18.9 Titer (1/dilution)
Interval 14.3 to 25.1
|
14.9 Titer (1/dilution)
Interval 11.9 to 18.6
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 2: Pre-injection 1
|
5.19 Titer (1/dilution)
Interval 4.82 to 5.58
|
5.22 Titer (1/dilution)
Interval 4.96 to 5.5
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 2: 28 days Post-injection 1
|
30.9 Titer (1/dilution)
Interval 22.9 to 41.8
|
24.2 Titer (1/dilution)
Interval 18.0 to 32.4
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 2: Pre-injection 2
|
38.4 Titer (1/dilution)
Interval 26.2 to 56.1
|
40.0 Titer (1/dilution)
Interval 28.9 to 55.3
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 2: 28 days Post-injection 2
|
64.1 Titer (1/dilution)
Interval 47.3 to 86.9
|
66.9 Titer (1/dilution)
Interval 50.9 to 87.9
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 3: Pre-injection 1
|
5.32 Titer (1/dilution)
Interval 4.94 to 5.73
|
5.28 Titer (1/dilution)
Interval 5.03 to 5.55
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 3: 28 days Post-injection 1
|
32.5 Titer (1/dilution)
Interval 23.8 to 44.4
|
31.0 Titer (1/dilution)
Interval 22.9 to 41.8
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 3: Pre-injection 2
|
26.2 Titer (1/dilution)
Interval 19.3 to 35.5
|
34.5 Titer (1/dilution)
Interval 25.3 to 47.1
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 3: 28 days Post-injection 2
|
47.9 Titer (1/dilution)
Interval 36.1 to 63.5
|
62.0 Titer (1/dilution)
Interval 46.8 to 82.2
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 4: Pre-injection 1
|
5.78 Titer (1/dilution)
Interval 5.16 to 6.48
|
5.11 Titer (1/dilution)
Interval 4.9 to 5.33
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 4: 28 days Post-injection 1
|
121 Titer (1/dilution)
Interval 74.2 to 197.0
|
126 Titer (1/dilution)
Interval 77.5 to 204.0
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 4: Pre-injection 2
|
60.2 Titer (1/dilution)
Interval 42.2 to 85.8
|
89.8 Titer (1/dilution)
Interval 58.6 to 138.0
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 4: 28 days Post-injection 2
|
104 Titer (1/dilution)
Interval 75.0 to 144.0
|
111 Titer (1/dilution)
Interval 78.1 to 159.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-injection 1 and 2 and 28 days post-injection 1 and 2Population: Analysis was performed on Full 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 Group 3 and 4.
Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer \>=10 (1/dilution).
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=117 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
|
CYD Dengue Vaccine: Group 2
n=119 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
|
CYD Dengue and Yellow Fever Vaccine: Group 3
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
|
Yellow Fever Vaccine: Group 4
Participants received single dose of YF vaccine at Day 0.
|
|---|---|---|---|---|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 1: Pre-injection 1
|
1.7 Percentage of participants
|
2.5 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 1: 28 days Post-injection 1
|
34.2 Percentage of participants
|
24.6 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 1: Pre-injection 2
|
35.5 Percentage of participants
|
35.6 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 1: 28 days Post-injection 2
|
58.4 Percentage of participants
|
52.6 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 2: Pre-injection 1
|
0.9 Percentage of participants
|
2.5 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 2: 28 days Post-injection 1
|
65.0 Percentage of participants
|
56.3 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 2: Pre-injection 2
|
61.3 Percentage of participants
|
68.6 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 2: 28 days Post-injection 2
|
86.1 Percentage of participants
|
87.9 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 3: Pre-injection 1
|
2.6 Percentage of participants
|
4.2 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 3: 28 days Post-injection 1
|
63.2 Percentage of participants
|
64.1 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 3: Pre-injection 2
|
61.7 Percentage of participants
|
66.1 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 3: 28 days Post-injection 2
|
80.2 Percentage of participants
|
84.5 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 4: Pre-injection 1
|
6.8 Percentage of participants
|
0.8 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 4: 28 days Post-injection 1
|
67.8 Percentage of participants
|
67.5 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 4: Pre-injection 2
|
71.7 Percentage of participants
|
67.5 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Dengue Virus Serotype 4: 28 days Post-injection 2
|
84.2 Percentage of participants
|
80.5 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-injection 1 and 28 days post-injection 1Population: Analysis was performed on Full Analysis Set. Here, "Overall number of participants analyzed = participants evaluable for this outcome measure" and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 4.
GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test-50 (PRNT50). Groups 1 and 2 data was reported as pooled data. YF-non immune participants were defined as participants with YF baseline titer PRNT80 \< 10 (1/dilution).
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=116 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
|
CYD Dengue Vaccine: Group 2
n=108 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
|
CYD Dengue and Yellow Fever Vaccine: Group 3
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
|
Yellow Fever Vaccine: Group 4
Participants received single dose of YF vaccine at Day 0.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 In YF Non-Immune Participants: Group 1 and Group 2 (Pooled) and Group 3
Dengue Virus Serotype 4: 28 days Post-injection 1
|
229 Titer (1/dilution)
Interval 139.0 to 378.0
|
22.6 Titer (1/dilution)
Interval 15.9 to 32.3
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 In YF Non-Immune Participants: Group 1 and Group 2 (Pooled) and Group 3
Dengue Virus Serotype 2: 28 days Post-injection 1
|
18.8 Titer (1/dilution)
Interval 13.9 to 25.3
|
10.8 Titer (1/dilution)
Interval 8.63 to 13.4
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 In YF Non-Immune Participants: Group 1 and Group 2 (Pooled) and Group 3
Dengue Virus Serotype 4: Pre-injection 1
|
5.43 Titer (1/dilution)
Interval 4.99 to 5.92
|
5.26 Titer (1/dilution)
Interval 4.9 to 5.65
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 In YF Non-Immune Participants: Group 1 and Group 2 (Pooled) and Group 3
Dengue Virus Serotype 3: Pre-injection 1
|
5.21 Titer (1/dilution)
Interval 4.97 to 5.47
|
5.28 Titer (1/dilution)
Interval 4.9 to 5.69
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 In YF Non-Immune Participants: Group 1 and Group 2 (Pooled) and Group 3
Dengue Virus Serotype 3: 28 days Post-injection 1
|
28.5 Titer (1/dilution)
Interval 20.4 to 39.7
|
8.88 Titer (1/dilution)
Interval 7.23 to 10.9
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 In YF Non-Immune Participants: Group 1 and Group 2 (Pooled) and Group 3
Dengue Virus Serotype 1: Pre-injection 1
|
5.19 Titer (1/dilution)
Interval 4.87 to 5.53
|
5.00 Titer (1/dilution)
The confidence interval (CI) of Geometric Mean was not calculated when standard deviation (SD) = 0.
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 In YF Non-Immune Participants: Group 1 and Group 2 (Pooled) and Group 3
Dengue Virus Serotype 1: 28 days Post-injection 1
|
8.71 Titer (1/dilution)
Interval 7.04 to 10.8
|
7.68 Titer (1/dilution)
Interval 6.46 to 9.14
|
—
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 In YF Non-Immune Participants: Group 1 and Group 2 (Pooled) and Group 3
Dengue Virus Serotype 2: Pre-injection 1
|
5.06 Titer (1/dilution)
Interval 4.94 to 5.19
|
5.06 Titer (1/dilution)
Interval 4.94 to 5.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-injection 1 and 28 days post-injection 1Population: Analysis was performed on Full Analysis Set. Here, "Overall number of participants analyzed = participants evaluable for this outcome measure" and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 4.
Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer \>=10 (1/dilution). Groups 1 and 2 data was reported as pooled data. YF-non immune participants were defined as participants with YF baseline titer dengue plaque reduction neutralization test-80 (PRNT80) \<10 (1/dilution).
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=116 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
|
CYD Dengue Vaccine: Group 2
n=108 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
|
CYD Dengue and Yellow Fever Vaccine: Group 3
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
|
Yellow Fever Vaccine: Group 4
Participants received single dose of YF vaccine at Day 0.
|
|---|---|---|---|---|
|
Percentage of YF Non-Immune Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1: Group 1 and Group 2 (Pooled) and Group 3
Dengue Virus Serotype 1: Pre-injection 1
|
1.7 percentage of participants
|
0.0 percentage of participants
|
—
|
—
|
|
Percentage of YF Non-Immune Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1: Group 1 and Group 2 (Pooled) and Group 3
Dengue Virus Serotype 1: 28 days Post-injection 1
|
23.3 percentage of participants
|
20.4 percentage of participants
|
—
|
—
|
|
Percentage of YF Non-Immune Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1: Group 1 and Group 2 (Pooled) and Group 3
Dengue Virus Serotype 2: Pre-injection 1
|
0.9 percentage of participants
|
0.9 percentage of participants
|
—
|
—
|
|
Percentage of YF Non-Immune Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1: Group 1 and Group 2 (Pooled) and Group 3
Dengue Virus Serotype 2: 28 days Post-injection 1
|
46.6 percentage of participants
|
35.2 percentage of participants
|
—
|
—
|
|
Percentage of YF Non-Immune Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1: Group 1 and Group 2 (Pooled) and Group 3
Dengue Virus Serotype 3: Pre-injection 1
|
2.6 percentage of participants
|
2.8 percentage of participants
|
—
|
—
|
|
Percentage of YF Non-Immune Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1: Group 1 and Group 2 (Pooled) and Group 3
Dengue Virus Serotype 3: 28 days Post-injection 1
|
57.9 percentage of participants
|
25.0 percentage of participants
|
—
|
—
|
|
Percentage of YF Non-Immune Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1: Group 1 and Group 2 (Pooled) and Group 3
Dengue Virus Serotype 4: Pre-injection 1
|
3.4 percentage of participants
|
1.9 percentage of participants
|
—
|
—
|
|
Percentage of YF Non-Immune Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1: Group 1 and Group 2 (Pooled) and Group 3
Dengue Virus Serotype 4: 28 days Post-injection 1
|
74.6 percentage of participants
|
48.6 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre Injection 1, 2 and 3 and 28 days post injection 1, 2 and 3Population: Analysis was performed on Full Analysis Set. Here, Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. FV immune participants were defined as participants with titer \>= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer \>= 10 (1/dilution) for YF virus (sera with PRNT80 result).
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=63 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
|
CYD Dengue Vaccine: Group 2
n=65 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
|
CYD Dengue and Yellow Fever Vaccine: Group 3
n=11 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
|
Yellow Fever Vaccine: Group 4
Participants received single dose of YF vaccine at Day 0.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 1: Pre-injection 1
|
5.73 Titer (1/dilution)
Interval 4.72 to 6.94
|
5.23 Titer (1/dilution)
Interval 4.96 to 5.53
|
14.3 Titer (1/dilution)
Interval 2.79 to 73.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 1: 28 days Post-injection 1
|
13.9 Titer (1/dilution)
Interval 9.46 to 20.3
|
9.25 Titer (1/dilution)
Interval 6.96 to 12.3
|
27.2 Titer (1/dilution)
Interval 5.96 to 124.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 1: Pre-injection 2
|
18.0 Titer (1/dilution)
Interval 11.9 to 27.1
|
12.8 Titer (1/dilution)
Interval 9.22 to 17.8
|
36.1 Titer (1/dilution)
Interval 5.89 to 221.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 1: 28 days Post-injection 2
|
25.0 Titer (1/dilution)
Interval 16.6 to 37.8
|
16.7 Titer (1/dilution)
Interval 12.6 to 22.2
|
31.4 Titer (1/dilution)
Interval 8.55 to 115.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 1: Pre-injection 3
|
12.7 Titer (1/dilution)
Interval 8.67 to 18.6
|
10.6 Titer (1/dilution)
Interval 7.98 to 14.1
|
36.3 Titer (1/dilution)
Interval 5.08 to 260.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 1: 28 days Post-injection 3
|
15.6 Titer (1/dilution)
Interval 10.6 to 23.0
|
17.2 Titer (1/dilution)
Interval 12.7 to 23.3
|
79.0 Titer (1/dilution)
Interval 17.2 to 362.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 2: Pre-injection 1
|
5.35 Titer (1/dilution)
Interval 4.67 to 6.13
|
5.42 Titer (1/dilution)
Interval 4.93 to 5.96
|
13.5 Titer (1/dilution)
Interval 3.71 to 49.4
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 2: 28 days Post-injection 1
|
48.1 Titer (1/dilution)
Interval 32.8 to 70.5
|
34.4 Titer (1/dilution)
Interval 23.0 to 51.4
|
66.3 Titer (1/dilution)
Interval 18.9 to 233.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 2: Pre-injection 2
|
72.3 Titer (1/dilution)
Interval 42.3 to 123.0
|
45.0 Titer (1/dilution)
Interval 29.8 to 67.9
|
70.2 Titer (1/dilution)
Interval 18.1 to 272.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 2: 28 days Post-injection 2
|
83.7 Titer (1/dilution)
Interval 54.6 to 128.0
|
74.6 Titer (1/dilution)
Interval 54.5 to 102.0
|
122 Titer (1/dilution)
Interval 38.4 to 386.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 2: Pre-injection 3
|
43.0 Titer (1/dilution)
Interval 25.9 to 71.3
|
62.3 Titer (1/dilution)
Interval 42.1 to 92.1
|
63.6 Titer (1/dilution)
Interval 18.7 to 217.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 2: 28 days Post-injection 3
|
60.0 Titer (1/dilution)
Interval 39.4 to 91.4
|
68.1 Titer (1/dilution)
Interval 48.9 to 94.7
|
133 Titer (1/dilution)
Interval 56.8 to 313.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 3: Pre-injection 1
|
5.61 Titer (1/dilution)
Interval 4.89 to 6.45
|
5.53 Titer (1/dilution)
Interval 5.06 to 6.05
|
21.5 Titer (1/dilution)
Interval 6.05 to 76.2
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 3: 28 days Post-injection 1
|
45.1 Titer (1/dilution)
Interval 30.5 to 66.8
|
31.2 Titer (1/dilution)
Interval 21.2 to 46.1
|
98.0 Titer (1/dilution)
Interval 51.6 to 186.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 3: Pre-injection 2
|
47.8 Titer (1/dilution)
Interval 33.0 to 69.2
|
41.1 Titer (1/dilution)
Interval 27.1 to 62.4
|
105 Titer (1/dilution)
Interval 27.7 to 396.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 3: 28 days Post-injection 2
|
72.5 Titer (1/dilution)
Interval 51.6 to 102.0
|
69.6 Titer (1/dilution)
Interval 49.9 to 97.0
|
158 Titer (1/dilution)
Interval 64.1 to 391.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 3: Pre-injection 3
|
29.9 Titer (1/dilution)
Interval 20.4 to 43.7
|
48.3 Titer (1/dilution)
Interval 33.9 to 68.7
|
106 Titer (1/dilution)
Interval 21.7 to 516.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 3: 28 days Post-injection 3
|
44.8 Titer (1/dilution)
Interval 31.3 to 64.3
|
71.2 Titer (1/dilution)
Interval 53.4 to 94.8
|
130 Titer (1/dilution)
Interval 36.3 to 463.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 4: Pre-injection 1
|
6.55 Titer (1/dilution)
Interval 5.32 to 8.07
|
5.20 Titer (1/dilution)
Interval 4.81 to 5.63
|
15.6 Titer (1/dilution)
Interval 5.33 to 45.6
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 4: 28 days Post-injection 1
|
78.2 Titer (1/dilution)
Interval 42.4 to 144.0
|
77.9 Titer (1/dilution)
Interval 42.1 to 144.0
|
215 Titer (1/dilution)
Interval 49.9 to 924.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 4: Pre-injection 2
|
65.9 Titer (1/dilution)
Interval 40.8 to 107.0
|
65.0 Titer (1/dilution)
Interval 37.9 to 111.0
|
235 Titer (1/dilution)
Interval 52.1 to 1059.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 4: 28 days Post-injection 2
|
89.6 Titer (1/dilution)
Interval 55.9 to 144.0
|
88.8 Titer (1/dilution)
Interval 56.0 to 141.0
|
223 Titer (1/dilution)
Interval 65.3 to 763.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 4: Pre-injection 3
|
40.0 Titer (1/dilution)
Interval 25.9 to 61.6
|
68.3 Titer (1/dilution)
Interval 45.0 to 104.0
|
146 Titer (1/dilution)
Interval 40.0 to 531.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 4: 28 days Post-injection 3
|
51.7 Titer (1/dilution)
Interval 35.1 to 76.2
|
78.5 Titer (1/dilution)
Interval 54.3 to 114.0
|
182 Titer (1/dilution)
Interval 103.0 to 319.0
|
—
|
SECONDARY outcome
Timeframe: Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3Population: Analysis was performed on Full Analysis Set. Here, Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 4.
GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. FV non-immune participants were defined as participants with titer \< 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer \<10 (1/dilution) for YF virus (using sera with PRNT80 result).
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=54 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
|
CYD Dengue Vaccine: Group 2
n=54 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
|
CYD Dengue and Yellow Fever Vaccine: Group 3
n=103 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
|
Yellow Fever Vaccine: Group 4
Participants received single dose of YF vaccine at Day 0.
|
|---|---|---|---|---|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 3: 28 days Post-injection 3
|
46.9 Titer (1/dilution)
Interval 30.9 to 71.2
|
47.3 Titer (1/dilution)
Interval 32.5 to 69.0
|
30.2 Titer (1/dilution)
Interval 22.8 to 40.1
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 1: Pre-injection 1
|
5.00 Titer (1/dilution)
The CI of Geometric Mean was not calculated when SD = 0.
|
5.00 Titer (1/dilution)
The CI of Geometric Mean was not calculated when SD = 0.
|
5.00 Titer (1/dilution)
The CI of Geometric Mean was not calculated when SD = 0.
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 1: 28 days Post-injection 1
|
7.31 Titer (1/dilution)
Interval 5.79 to 9.23
|
8.18 Titer (1/dilution)
Interval 6.22 to 10.8
|
7.50 Titer (1/dilution)
Interval 6.3 to 8.92
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 1: Pre-injection 2
|
6.73 Titer (1/dilution)
Interval 5.49 to 8.23
|
10.1 Titer (1/dilution)
Interval 7.4 to 13.7
|
7.76 Titer (1/dilution)
Interval 6.46 to 9.32
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 1: 28 days Post-injection 2
|
13.9 Titer (1/dilution)
Interval 9.64 to 20.2
|
13.0 Titer (1/dilution)
Interval 9.12 to 18.5
|
10.9 Titer (1/dilution)
Interval 8.55 to 14.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 1: Pre-injection 3
|
6.71 Titer (1/dilution)
Interval 5.54 to 8.13
|
8.97 Titer (1/dilution)
Interval 6.7 to 12.0
|
10.8 Titer (1/dilution)
Interval 8.52 to 13.8
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 1: 28 days Post-injection 3
|
13.9 Titer (1/dilution)
Interval 9.49 to 20.4
|
14.4 Titer (1/dilution)
Interval 10.1 to 20.7
|
18.5 Titer (1/dilution)
Interval 13.9 to 24.8
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 2: Pre-injection 1
|
5.00 Titer (1/dilution)
The CI of Geometric Mean was not calculated when SD = 0.
|
5.00 Titer (1/dilution)
The CI of Geometric Mean was not calculated when SD = 0.
|
5.00 Titer (1/dilution)
The CI of Geometric Mean was not calculated when SD = 0.
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 2: 28 days Post-injection 1
|
18.5 Titer (1/dilution)
Interval 11.8 to 28.9
|
15.8 Titer (1/dilution)
Interval 10.4 to 23.9
|
10.3 Titer (1/dilution)
Interval 8.26 to 13.0
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 2: Pre-injection 2
|
18.9 Titer (1/dilution)
Interval 11.6 to 30.7
|
34.6 Titer (1/dilution)
Interval 20.4 to 58.6
|
11.6 Titer (1/dilution)
Interval 8.87 to 15.1
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 2: 28 days Post-injection 2
|
47.8 Titer (1/dilution)
Interval 31.0 to 73.7
|
58.8 Titer (1/dilution)
Interval 36.5 to 94.8
|
30.8 Titer (1/dilution)
Interval 22.3 to 42.6
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 2: Pre-injection 3
|
18.2 Titer (1/dilution)
Interval 12.0 to 27.7
|
32.4 Titer (1/dilution)
Interval 21.5 to 48.9
|
23.1 Titer (1/dilution)
Interval 16.3 to 32.9
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 2: 28 days Post-injection 3
|
42.1 Titer (1/dilution)
Interval 27.9 to 63.4
|
51.4 Titer (1/dilution)
Interval 32.8 to 80.6
|
46.4 Titer (1/dilution)
Interval 33.8 to 63.6
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 3: Pre-injection 1
|
5.00 Titer (1/dilution)
The CI of Geometric Mean was not calculated when SD = 0.
|
5.00 Titer (1/dilution)
The CI of Geometric Mean was not calculated when SD = 0.
|
5.00 Titer (1/dilution)
The CI of Geometric Mean was not calculated when SD = 0.
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 3: 28 days Post-injection 1
|
22.2 Titer (1/dilution)
Interval 13.6 to 36.2
|
30.7 Titer (1/dilution)
Interval 18.8 to 49.9
|
8.00 Titer (1/dilution)
Interval 6.6 to 9.71
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 3: Pre-injection 2
|
13.5 Titer (1/dilution)
Interval 8.76 to 20.8
|
27.8 Titer (1/dilution)
Interval 17.3 to 44.8
|
9.06 Titer (1/dilution)
Interval 7.18 to 11.4
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 3: 28 days Post-injection 2
|
30.3 Titer (1/dilution)
Interval 19.5 to 46.8
|
54.1 Titer (1/dilution)
Interval 33.3 to 87.8
|
18.5 Titer (1/dilution)
Interval 13.6 to 25.2
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 3: Pre-injection 3
|
19.8 Titer (1/dilution)
Interval 13.5 to 29.1
|
27.2 Titer (1/dilution)
Interval 18.3 to 40.3
|
17.5 Titer (1/dilution)
Interval 12.9 to 23.6
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 4: Pre-injection 1
|
5.00 Titer (1/dilution)
The CI of Geometric Mean was not calculated when SD = 0.
|
5.00 Titer (1/dilution)
The CI of Geometric Mean was not calculated when SD = 0.
|
5.00 Titer (1/dilution)
The CI of Geometric Mean was not calculated when SD = 0.
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 4: 28 days Post-injection 1
|
197 Titer (1/dilution)
Interval 90.9 to 428.0
|
229 Titer (1/dilution)
Interval 107.0 to 488.0
|
20.5 Titer (1/dilution)
Interval 14.3 to 29.4
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 4: Pre-injection 2
|
54.4 Titer (1/dilution)
Interval 31.6 to 93.5
|
135 Titer (1/dilution)
Interval 67.5 to 268.0
|
18.2 Titer (1/dilution)
Interval 12.6 to 26.3
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 4: 28 days Post-injection 2
|
122 Titer (1/dilution)
Interval 77.3 to 193.0
|
145 Titer (1/dilution)
Interval 83.0 to 253.0
|
42.8 Titer (1/dilution)
Interval 29.2 to 62.7
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 4: Pre-injection 3
|
62.8 Titer (1/dilution)
Interval 39.2 to 101.0
|
82.9 Titer (1/dilution)
Interval 48.2 to 143.0
|
47.8 Titer (1/dilution)
Interval 34.2 to 66.7
|
—
|
|
Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 4: 28 days Post-injection 3
|
91.8 Titer (1/dilution)
Interval 63.3 to 133.0
|
89.2 Titer (1/dilution)
Interval 53.3 to 149.0
|
71.2 Titer (1/dilution)
Interval 52.0 to 97.7
|
—
|
SECONDARY outcome
Timeframe: Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3Population: Analysis was performed on Full Analysis Set. Here, Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer \>=10 (1/dilution). FV immune participants at baseline were defined as participants with titer \>= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer \>=10 (1/dilution) for YF virus (sera with PRNT80 result).
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=63 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
|
CYD Dengue Vaccine: Group 2
n=65 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
|
CYD Dengue and Yellow Fever Vaccine: Group 3
n=11 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
|
Yellow Fever Vaccine: Group 4
Participants received single dose of YF vaccine at Day 0.
|
|---|---|---|---|---|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 1: Pre-injection 1
|
3.2 percentage of participants
|
4.6 percentage of participants
|
18.2 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 1: 28 days Post-injection 1
|
47.6 percentage of participants
|
26.6 percentage of participants
|
45.5 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 1: Pre-injection 2
|
51.8 percentage of participants
|
38.5 percentage of participants
|
54.5 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 1: 28 days Post-injection 2
|
67.9 percentage of participants
|
61.9 percentage of participants
|
70.0 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 1: Pre-injection 3
|
45.1 percentage of participants
|
36.2 percentage of participants
|
55.6 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 1: 28 days Post-injection 3
|
54.9 percentage of participants
|
61.0 percentage of participants
|
88.9 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 2: Pre-injection 1
|
1.6 percentage of participants
|
4.6 percentage of participants
|
27.3 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 2: 28 days Post-injection 1
|
79.4 percentage of participants
|
69.2 percentage of participants
|
81.8 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 2: Pre-injection 2
|
75.0 percentage of participants
|
75.4 percentage of participants
|
72.7 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 2: 28 days Post-injection 2
|
88.7 percentage of participants
|
95.2 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 2: Pre-injection 3
|
70.6 percentage of participants
|
86.7 percentage of participants
|
88.9 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 2: 28 days Post-injection 3
|
84.6 percentage of participants
|
94.9 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 3: Pre-injection 1
|
4.8 percentage of participants
|
7.7 percentage of participants
|
54.5 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 3: 28 days Post-injection 1
|
74.6 percentage of participants
|
66.2 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 3: Pre-injection 2
|
80.4 percentage of participants
|
70.8 percentage of participants
|
81.8 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 3: 28 days Post-injection 2
|
90.6 percentage of participants
|
92.1 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 3: Pre-injection 3
|
74.5 percentage of participants
|
85.0 percentage of participants
|
77.8 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 3: 28 days Post-injection 3
|
84.6 percentage of participants
|
94.9 percentage of participants
|
88.9 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 4: Pre-injection 1
|
12.7 percentage of participants
|
1.5 percentage of participants
|
36.4 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 4: 28 days Post-injection 1
|
65.6 percentage of participants
|
61.5 percentage of participants
|
90.9 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 4: Pre-injection 2
|
76.8 percentage of participants
|
63.1 percentage of participants
|
90.9 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 4: 28 days Post-injection 2
|
81.1 percentage of participants
|
78.7 percentage of participants
|
100.0 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 4: Pre-injection 3
|
74.5 percentage of participants
|
76.7 percentage of participants
|
88.9 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Dengue Virus Serotype 4: 28 days Post-injection 3
|
82.7 percentage of participants
|
88.1 percentage of participants
|
100.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Pre injection 1, 2, 3 and 28 days post injection 1, 2 and 3Population: Analysis was performed on Full Analysis Set. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer \>=10 (1/dilution). FV non-immune participants were defined as participants with titer \< 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer \<10 (1/dilution) for YF virus (using sera with PRNT80 result).
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=54 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
|
CYD Dengue Vaccine: Group 2
n=54 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
|
CYD Dengue and Yellow Fever Vaccine: Group 3
n=103 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
|
Yellow Fever Vaccine: Group 4
Participants received single dose of YF vaccine at Day 0.
|
|---|---|---|---|---|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 3: Pre-injection 3
|
63.8 percentage of participants
|
68.0 percentage of participants
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 3: 28 days Post-injection 3
|
85.7 percentage of participants
|
85.4 percentage of participants
|
73.5 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 1: Pre-injection 1
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 1: 28 days Post-injection 1
|
18.5 percentage of participants
|
22.2 percentage of participants
|
19.4 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 1: Pre-injection 2
|
17.6 percentage of participants
|
32.1 percentage of participants
|
22.0 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 1: 28 days Post-injection 2
|
47.9 percentage of participants
|
41.5 percentage of participants
|
36.7 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 1: Pre-injection 3
|
19.1 percentage of participants
|
28.0 percentage of participants
|
39.3 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 1: 28 days Post-injection 3
|
50.0 percentage of participants
|
51.0 percentage of participants
|
59.5 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 2: Pre-injection 1
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 2: 28 days Post-injection 1
|
48.1 percentage of participants
|
40.7 percentage of participants
|
33.0 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 2: Pre-injection 2
|
46.0 percentage of participants
|
60.4 percentage of participants
|
33.0 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 2: 28 days Post-injection 2
|
83.3 percentage of participants
|
79.2 percentage of participants
|
68.9 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 2: Pre-injection 3
|
55.3 percentage of participants
|
72.5 percentage of participants
|
57.0 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 2: 28 days Post-injection 3
|
83.3 percentage of participants
|
79.6 percentage of participants
|
83.3 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 3: Pre-injection 1
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 3: 28 days Post-injection 1
|
50.0 percentage of participants
|
61.5 percentage of participants
|
21.4 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 3: Pre-injection 2
|
41.2 percentage of participants
|
60.4 percentage of participants
|
26.0 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 3: 28 days Post-injection 2
|
68.8 percentage of participants
|
75.5 percentage of participants
|
52.2 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 4: Pre-injection 1
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 4: 28 days Post-injection 1
|
70.4 percentage of participants
|
75.0 percentage of participants
|
46.1 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 4: Pre-injection 2
|
66.0 percentage of participants
|
73.1 percentage of participants
|
41.0 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 4: 28 days Post-injection 2
|
87.5 percentage of participants
|
82.7 percentage of participants
|
67.8 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 4: Pre-injection 3
|
80.9 percentage of participants
|
79.6 percentage of participants
|
77.6 percentage of participants
|
—
|
|
Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Dengue Virus Serotype 4: 28 days Post-injection 3
|
95.2 percentage of participants
|
83.3 percentage of participants
|
84.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Within 7 days after any injectionPopulation: Analysis was performed on Safety Analysis set which included participants who received at least one injection of CYD dengue vaccine or YF vaccine. Here, "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions: Pain: significant; prevents daily activity; Erythema and Swelling: \>100 mm.
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=118 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
|
CYD Dengue Vaccine: Group 2
n=119 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
|
CYD Dengue and Yellow Fever Vaccine: Group 3
n=115 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
|
Yellow Fever Vaccine: Group 4
n=27 Participants
Participants received single dose of YF vaccine at Day 0.
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Any Injection site Swelling: CYD Dengue Vaccine
|
5 Participants
|
2 Participants
|
0 Participants
|
NA Participants
CYD Dengue vaccine was not administered to the specified group.
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Grade 3 Swelling: CYD Dengue Vaccine
|
0 Participants
|
0 Participants
|
0 Participants
|
NA Participants
CYD Dengue vaccine was not administered to the specified group.
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Any Injection site Swelling: Yellow Fever Vaccine
|
NA Participants
Yellow Fever vaccine was not administered to the specified group.
|
NA Participants
Yellow Fever vaccine was not administered to the specified group.
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Grade 3 Swelling: Yellow Fever Vaccine
|
NA Participants
Yellow Fever vaccine was not administered to the specified group.
|
NA Participants
Yellow Fever vaccine was not administered to the specified group.
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Grade 3 Erythema: Yellow Fever Vaccine
|
NA Participants
Yellow Fever vaccine was not administered to the specified group.
|
NA Participants
Yellow Fever vaccine was not administered to the specified group.
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Any Injection site Pain: CYD Dengue Vaccine
|
44 Participants
|
59 Participants
|
51 Participants
|
NA Participants
CYD Dengue vaccine was not administered to the specified group.
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Grade 3 Pain: CYD Dengue Vaccine
|
0 Participants
|
3 Participants
|
1 Participants
|
NA Participants
CYD Dengue vaccine was not administered to the specified group.
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Any Injection site Pain: Yellow Fever Vaccine
|
NA Participants
Yellow Fever vaccine was not administered to the specified group.
|
NA Participants
Yellow Fever vaccine was not administered to the specified group.
|
53 Participants
|
10 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Grade 3 Pain: Yellow Fever Vaccine
|
NA Participants
Yellow Fever vaccine was not administered to the specified group.
|
NA Participants
Yellow Fever vaccine was not administered to the specified group.
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Any Injection site Erythema: CYD Dengue Vaccine
|
5 Participants
|
10 Participants
|
1 Participants
|
NA Participants
CYD Dengue vaccine was not administered to the specified group.
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Grade 3 Erythema: CYD Dengue Vaccine
|
0 Participants
|
0 Participants
|
0 Participants
|
NA Participants
CYD Dengue vaccine was not administered to the specified group.
|
|
Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Any Injection site Erythema: Yellow Fever Vaccine
|
NA Participants
Yellow Fever vaccine was not administered to the specified group.
|
NA Participants
Yellow Fever vaccine was not administered to the specified group.
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 14 days after any injectionPopulation: Analysis was performed on Safety Analysis Set. Here, 'Number analyzed' = participants with available data for each specified category.
Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: \>= 39.0°C; Headache, Malaise, Myalgia, and Asthenia: significant; prevents daily activity.
Outcome measures
| Measure |
CYD Dengue Vaccine: Group 1
n=120 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
|
CYD Dengue Vaccine: Group 2
n=120 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
|
CYD Dengue and Yellow Fever Vaccine: Group 3
n=119 Participants
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
|
Yellow Fever Vaccine: Group 4
n=30 Participants
Participants received single dose of YF vaccine at Day 0.
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Fever: Any Grade
|
7 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Headache: Any Grade
|
59 Participants
|
60 Participants
|
64 Participants
|
11 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Myalgia: Grade 3
|
6 Participants
|
3 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Asthenia: Any Grade
|
41 Participants
|
36 Participants
|
40 Participants
|
9 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Fever: Grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Headache: Grade 3
|
4 Participants
|
5 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Malaise: Any Grade
|
63 Participants
|
53 Participants
|
53 Participants
|
12 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Malaise: Grade 3
|
10 Participants
|
8 Participants
|
10 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Myalgia: Any Grade
|
51 Participants
|
47 Participants
|
54 Participants
|
8 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Asthenia: Grade 3
|
6 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
Adverse Events
CYD Dengue Vaccine: Group 1
Serious events: 4 serious events
Other events: 91 other events
Deaths: 0 deaths
CYD Dengue Vaccine: Group 2
Serious events: 4 serious events
Other events: 92 other events
Deaths: 0 deaths
CYD Dengue and Yellow Fever Vaccine: Group 3
Serious events: 5 serious events
Other events: 92 other events
Deaths: 0 deaths
Yellow Fever Vaccine: Group 4
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CYD Dengue Vaccine: Group 1
n=120 participants at risk
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
|
CYD Dengue Vaccine: Group 2
n=120 participants at risk
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
|
CYD Dengue and Yellow Fever Vaccine: Group 3
n=119 participants at risk
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
|
Yellow Fever Vaccine: Group 4
n=30 participants at risk
Participants received single dose of YF vaccine at Day 0.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.83%
1/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/119 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Abdominal Abscess
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.83%
1/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/119 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Appendicitis
|
0.83%
1/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/119 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Diverticulitis
|
0.83%
1/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/119 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Pneumonia
|
0.83%
1/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/119 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.84%
1/119 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.84%
1/119 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Toxicity To Various Agents
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.84%
1/119 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.83%
1/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/119 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.84%
1/119 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.83%
1/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/119 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vaginal Cancer
|
0.83%
1/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/119 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Blighted Ovum
|
0.83%
1/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/119 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.83%
1/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/119 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.83%
1/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/119 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.83%
1/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/119 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.84%
1/119 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/120 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.84%
1/119 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
Other adverse events
| Measure |
CYD Dengue Vaccine: Group 1
n=120 participants at risk
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
|
CYD Dengue Vaccine: Group 2
n=120 participants at risk
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
|
CYD Dengue and Yellow Fever Vaccine: Group 3
n=119 participants at risk
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
|
Yellow Fever Vaccine: Group 4
n=30 participants at risk
Participants received single dose of YF vaccine at Day 0.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.3%
4/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
5.8%
7/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.84%
1/119 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Asthenia
|
34.2%
41/120 • Number of events 57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
30.0%
36/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
33.6%
40/119 • Number of events 57 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
30.0%
9/30 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Fatigue
|
0.83%
1/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
3.3%
4/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.84%
1/119 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
6.7%
2/30 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Injection Site Erythema
|
4.2%
5/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
8.3%
10/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.2%
5/119 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Injection Site Pain
|
36.7%
44/120 • Number of events 71 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
49.2%
59/120 • Number of events 97 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
52.9%
63/119 • Number of events 138 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
33.3%
10/30 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Malaise
|
52.5%
63/120 • Number of events 92 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
44.2%
53/120 • Number of events 93 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
44.5%
53/119 • Number of events 77 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
40.0%
12/30 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Pyrexia
|
5.8%
7/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
5.0%
6/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.2%
5/119 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
3.3%
1/30 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
5/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
5.8%
7/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
1.7%
2/119 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
42.5%
51/120 • Number of events 75 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
39.2%
47/120 • Number of events 78 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
45.4%
54/119 • Number of events 91 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
26.7%
8/30 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Headache
|
50.0%
60/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
50.8%
61/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
53.8%
64/119 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
36.7%
11/30 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
2/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
3.3%
4/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
5.9%
7/119 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
4.2%
5/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
5.8%
7/120 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
3.4%
4/119 • 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 and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/30 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months after the first injection).
Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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