Trial Outcomes & Findings for Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US (NCT NCT00617344)
NCT ID: NCT00617344
Last Updated: 2019-06-11
Results Overview
Percentage of participants with antibody titers \>= 10 (1/dil) against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by dengue plaque reduction neutralization test (PRNT).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
260 participants
Primary outcome timeframe
Pre-injection 1 (Day 0), 30 days post-injection 2 (Month 7)
Results posted on
2019-06-11
Participant Flow
Study participants were enrolled from 17 April 2008 to 04 June 2008 at 5 sites in the United States.
A total of 309 participants were screened in the study, out of which 260 participants were enrolled and vaccinated in the study. Screen failures were mainly due to inclusion criteria not met or exclusion criteria met.
Participant milestones
| Measure |
CYD Dengue Vaccine 5555 Formulation
Participants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 5553 Formulation
Participants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 4444 Formulation
Participants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
104
|
103
|
53
|
|
Overall Study
Received Vaccination 1
|
104
|
103
|
53
|
|
Overall Study
Received Vaccination 2
|
86
|
85
|
46
|
|
Overall Study
Received Vaccination 3
|
79
|
81
|
45
|
|
Overall Study
COMPLETED
|
79
|
81
|
45
|
|
Overall Study
NOT COMPLETED
|
25
|
22
|
8
|
Reasons for withdrawal
| Measure |
CYD Dengue Vaccine 5555 Formulation
Participants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 5553 Formulation
Participants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 4444 Formulation
Participants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
|---|---|---|---|
|
Overall Study
Serious adverse event
|
1
|
0
|
0
|
|
Overall Study
Other Adverse Event
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
10
|
8
|
5
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
9
|
2
|
Baseline Characteristics
Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US
Baseline characteristics by cohort
| Measure |
CYD Dengue Vaccine 5555 Formulation
n=101 Participants
Participants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 5553 Formulation
n=101 Participants
Participants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 4444 Formulation
n=53 Participants
Participants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.6 Years
STANDARD_DEVIATION 8.78 • n=5 Participants
|
32.1 Years
STANDARD_DEVIATION 8.57 • n=7 Participants
|
32.4 Years
STANDARD_DEVIATION 8.04 • n=5 Participants
|
32.4 Years
STANDARD_DEVIATION 8.52 • n=4 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
152 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-injection 1 (Day 0), 30 days post-injection 2 (Month 7)Population: Analysis was performed on Full Analysis Set (FAS). Here, 'number analyzed' = participants with available data for each specified category.
Percentage of participants with antibody titers \>= 10 (1/dil) against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by dengue plaque reduction neutralization test (PRNT).
Outcome measures
| Measure |
CYD Dengue Vaccine 5555 Formulation
n=101 Participants
Participants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 5553 Formulation
n=101 Participants
Participants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 4444 Formulation
Participants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
|---|---|---|---|
|
Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation
Dengue Virus Serotype 1: Day 0
|
1.0 percentage of participants
|
3.0 percentage of participants
|
—
|
|
Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation
Dengue Virus Serotype 1:30 days post injection-2
|
65.4 percentage of participants
|
81.0 percentage of participants
|
—
|
|
Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation
Dengue Virus Serotype 2: Day 0
|
1.0 percentage of participants
|
3.0 percentage of participants
|
—
|
|
Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation
Dengue Virus Serotype 2:30 days post-injection 2
|
80.2 percentage of participants
|
83.3 percentage of participants
|
—
|
|
Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation
Dengue Virus Serotype 3: Day 0
|
15.8 percentage of participants
|
14.9 percentage of participants
|
—
|
|
Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation
Dengue Virus Serotype 3:30 days post-injection 2
|
87.2 percentage of participants
|
92.9 percentage of participants
|
—
|
|
Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation
Dengue Virus Serotype 4: Day 0
|
3.0 percentage of participants
|
6.9 percentage of participants
|
—
|
|
Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation
Dengue Virus Serotype 4:30 days post-injection 2
|
89.7 percentage of participants
|
58.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13)Population: Analysis was performed on FAS population. Here, 'number analyzed' = participants with available data for each specified category.
Percentage of participants with antibody titers \>= 10 1/dil against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by PRNT.
Outcome measures
| Measure |
CYD Dengue Vaccine 5555 Formulation
n=101 Participants
Participants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 5553 Formulation
n=101 Participants
Participants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 4444 Formulation
n=53 Participants
Participants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
|---|---|---|---|
|
Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 1: Day 0
|
1.0 percentage of participants
|
3.0 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 1:30 days post-injection 1
|
33.7 percentage of participants
|
50.5 percentage of participants
|
26.4 percentage of participants
|
|
Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 1:30 days post-injection 2
|
65.4 percentage of participants
|
81.0 percentage of participants
|
58.7 percentage of participants
|
|
Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 1:30 days post-injection 3
|
71.0 percentage of participants
|
84.0 percentage of participants
|
64.4 percentage of participants
|
|
Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 2: Day 0
|
1.0 percentage of participants
|
3.0 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 2:30 days post-injection 1
|
46.5 percentage of participants
|
64.4 percentage of participants
|
34.0 percentage of participants
|
|
Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 2:30 days post-injection 2
|
80.2 percentage of participants
|
83.3 percentage of participants
|
58.7 percentage of participants
|
|
Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 2:30 days post-injection 3
|
84.3 percentage of participants
|
88.9 percentage of participants
|
77.8 percentage of participants
|
|
Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 3: Day 0
|
15.8 percentage of participants
|
14.9 percentage of participants
|
13.2 percentage of participants
|
|
Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 3:30 days post-injection 1
|
79.2 percentage of participants
|
80.2 percentage of participants
|
60.4 percentage of participants
|
|
Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 3:30 days post-injection 2
|
87.2 percentage of participants
|
92.9 percentage of participants
|
78.3 percentage of participants
|
|
Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 3:30 days post-injection 3
|
88.6 percentage of participants
|
98.8 percentage of participants
|
82.2 percentage of participants
|
|
Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 4: Day 0
|
3.0 percentage of participants
|
6.9 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 4:30 days post-injection 1
|
84.2 percentage of participants
|
37.6 percentage of participants
|
94.3 percentage of participants
|
|
Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 4:30 days post-injection 2
|
89.7 percentage of participants
|
58.3 percentage of participants
|
89.1 percentage of participants
|
|
Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 4:30 days post-injection 3
|
94.2 percentage of participants
|
69.1 percentage of participants
|
93.3 percentage of participants
|
SECONDARY outcome
Timeframe: Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13)Population: Analysis was performed on FAS population. Here, 'number analyzed' = participants with available data for each specified category.
Percentage of participants with antibody titers \>= 10 1/dil against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by PRNT. In this outcome measure, participants with antibody titers \>= 10 1/dil against any 1 of the 4 serotypes or any 2 of the 4 serotypes or any 3 of the 4 serotypes or with all 4 serotypes were reported.
Outcome measures
| Measure |
CYD Dengue Vaccine 5555 Formulation
n=101 Participants
Participants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 5553 Formulation
n=101 Participants
Participants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 4444 Formulation
n=53 Participants
Participants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
|---|---|---|---|
|
Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
At least 1 positive serotype: Day 0
|
16.8 percentage of participants
|
20.8 percentage of participants
|
17.0 percentage of participants
|
|
Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
At least 1 positive serotype: Post-injection 1
|
96.0 percentage of participants
|
93.1 percentage of participants
|
98.1 percentage of participants
|
|
Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
At least 1 positive serotype: Post-injection 2
|
97.6 percentage of participants
|
97.6 percentage of participants
|
97.8 percentage of participants
|
|
Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
At least 1 positive serotype: Post-injection 3
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
At least 2 positive serotype: Day 0
|
3.0 percentage of participants
|
3.0 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
At least 2 positive serotype: Post-injection 1
|
80.2 percentage of participants
|
74.3 percentage of participants
|
64.2 percentage of participants
|
|
Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
At least 2 positive serotype: Post-injection 2
|
90.2 percentage of participants
|
90.5 percentage of participants
|
82.6 percentage of participants
|
|
Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
At least 2 positive serotype: Post-injection 3
|
90.0 percentage of participants
|
95.1 percentage of participants
|
91.1 percentage of participants
|
|
Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
At least 3 positive serotype: Day 0
|
1.0 percentage of participants
|
2.0 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
At least 3 positive serotype: Post-injection 1
|
50.5 percentage of participants
|
45.5 percentage of participants
|
41.5 percentage of participants
|
|
Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
At least 3 positive serotype: Post-injection 2
|
72.0 percentage of participants
|
79.8 percentage of participants
|
63.0 percentage of participants
|
|
Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
At least 3 positive serotype: Post-injection 3
|
82.9 percentage of participants
|
86.4 percentage of participants
|
73.3 percentage of participants
|
|
Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
All 4 positive serotype: Day 0
|
0.0 percentage of participants
|
2.0 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
All 4 positive serotype: Post-injection 1
|
16.8 percentage of participants
|
19.8 percentage of participants
|
11.3 percentage of participants
|
|
Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
All 4 positive serotype: Post-injection 2
|
52.4 percentage of participants
|
47.6 percentage of participants
|
41.3 percentage of participants
|
|
Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
All 4 positive serotype: Post-injection 3
|
62.9 percentage of participants
|
59.3 percentage of participants
|
53.3 percentage of participants
|
SECONDARY outcome
Timeframe: Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13)Population: Analysis was performed on FAS population. Here, 'number analyzed' = participants with available data for each specified category.
Geometric mean titers against each dengue virus serotype (1, 2, 3 and 4) strain was measured by PRNT.
Outcome measures
| Measure |
CYD Dengue Vaccine 5555 Formulation
n=101 Participants
Participants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 5553 Formulation
n=101 Participants
Participants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 4444 Formulation
n=53 Participants
Participants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
|---|---|---|---|
|
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 1: Day 0
|
5.04 Titers (1/dil)
Interval 4.96 to 5.13
|
5.57 Titers (1/dil)
Interval 4.88 to 6.36
|
5.23 Titers (1/dil)
Interval 4.9 to 5.58
|
|
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 1:30 days post-injection 1
|
9.97 Titers (1/dil)
Interval 8.11 to 12.3
|
20.3 Titers (1/dil)
Interval 14.6 to 28.2
|
9.29 Titers (1/dil)
Interval 6.51 to 13.3
|
|
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 1:30 days post-injection 2
|
24.1 Titers (1/dil)
Interval 18.1 to 32.1
|
45.4 Titers (1/dil)
Interval 33.7 to 61.2
|
19.2 Titers (1/dil)
Interval 12.4 to 29.8
|
|
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 1:30 days post-injection 3
|
24.4 Titers (1/dil)
Interval 18.5 to 32.1
|
57.1 Titers (1/dil)
Interval 42.2 to 77.3
|
24.2 Titers (1/dil)
Interval 15.8 to 37.2
|
|
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 2: Day 0
|
5.13 Titers (1/dil)
Interval 4.87 to 5.4
|
5.53 Titers (1/dil)
Interval 4.93 to 6.2
|
5.43 Titers (1/dil)
Interval 4.6 to 6.42
|
|
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 2:30 days post-injection 1
|
16.7 Titers (1/dil)
Interval 12.3 to 22.6
|
39.9 Titers (1/dil)
Interval 27.9 to 57.3
|
13.1 Titers (1/dil)
Interval 8.6 to 20.0
|
|
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 2:30 days post-injection 2
|
47.5 Titers (1/dil)
Interval 33.4 to 67.4
|
91.9 Titers (1/dil)
Interval 60.7 to 139.0
|
31.8 Titers (1/dil)
Interval 18.6 to 54.3
|
|
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 2:30 days post-injection 3
|
54.8 Titers (1/dil)
Interval 38.7 to 77.7
|
102 Titers (1/dil)
Interval 72.7 to 143.0
|
46.5 Titers (1/dil)
Interval 29.1 to 74.2
|
|
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 3: Day 0
|
6.60 Titers (1/dil)
Interval 5.78 to 7.53
|
6.85 Titers (1/dil)
Interval 5.82 to 8.05
|
6.25 Titers (1/dil)
Interval 5.3 to 7.37
|
|
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 3:30 days post-injection 1
|
45.5 Titers (1/dil)
Interval 34.0 to 60.9
|
109 Titers (1/dil)
Interval 70.9 to 169.0
|
23.3 Titers (1/dil)
Interval 15.2 to 35.5
|
|
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 3:30 days post-injection 2
|
64.5 Titers (1/dil)
Interval 48.3 to 86.1
|
117 Titers (1/dil)
Interval 86.9 to 159.0
|
40.4 Titers (1/dil)
Interval 26.3 to 62.1
|
|
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 3:30 days post-injection 3
|
63.5 Titers (1/dil)
Interval 46.9 to 85.9
|
114 Titers (1/dil)
Interval 90.9 to 143.0
|
43.1 Titers (1/dil)
Interval 29.1 to 63.8
|
|
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 4: Day 0
|
5.26 Titers (1/dil)
Interval 4.96 to 5.59
|
5.57 Titers (1/dil)
Interval 5.12 to 6.06
|
5.43 Titers (1/dil)
Interval 4.92 to 5.99
|
|
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 4:30 days post-injection 1
|
438 Titers (1/dil)
Interval 273.0 to 704.0
|
12.1 Titers (1/dil)
Interval 9.26 to 15.9
|
643 Titers (1/dil)
Interval 370.0 to 1117.0
|
|
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 4:30 days post-injection 2
|
150 Titers (1/dil)
Interval 104.0 to 215.0
|
18.3 Titers (1/dil)
Interval 13.6 to 24.7
|
164 Titers (1/dil)
Interval 99.4 to 272.0
|
|
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Dengue Virus Serotype 4:30 days post-injection 3
|
133 Titers (1/dil)
Interval 98.6 to 179.0
|
25.9 Titers (1/dil)
Interval 18.7 to 36.0
|
134 Titers (1/dil)
Interval 86.3 to 207.0
|
SECONDARY outcome
Timeframe: 7 days after any injection 1, 2 or 3Population: Analysis was performed on Safety Analysis Set which included all participants included in the trial who had received at least 1 dose of study vaccine and had any available safety data. Here, 'number analyzed' = participants with available data for each specified category.
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 1: Easily tolerated, Grade 2: Sufficiently discomforting to interfere with normal behavior or activities, Grade 3: Incapacitating, unable to perform usual activities. Erythema:- Grade 1: \<2.5 cm, Grade 2: \>=2.5 to \<5 cm, Grade 3: \>=5 cm. Swelling:- Grade 1: \<2.5 cm, Grade 2: \>=2.5 to \<5 cm, Grade 3: \>=5 cm.
Outcome measures
| Measure |
CYD Dengue Vaccine 5555 Formulation
n=101 Participants
Participants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 5553 Formulation
n=101 Participants
Participants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 4444 Formulation
n=53 Participants
Participants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
|---|---|---|---|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Swelling: Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Pain
|
50 Participants
|
42 Participants
|
15 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Pain: Grade 1
|
46 Participants
|
35 Participants
|
15 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Pain: Grade 2
|
3 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Pain: Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Erythema
|
26 Participants
|
27 Participants
|
8 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Erythema: Grade 1
|
18 Participants
|
19 Participants
|
8 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Erythema: Grade 2
|
7 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Erythema: Grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Swelling
|
19 Participants
|
14 Participants
|
3 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Swelling: Grade 1
|
15 Participants
|
12 Participants
|
3 Participants
|
|
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Swelling: Grade 2
|
3 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 days after any injection 1, 2 or 3Population: 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. Fever: - Grade1: \>=37.5°C to \<=38.0°C (\>=99.5°F to \<=100.4°F), Grade 2: \>38.0°C to \<=39.0°C (\>100.4°F to \<= 102.2°F), Grade 3: \>39.0°C (\>102.2°F). Headache, malaise, myalgia and asthenia: Grade 1: noticeable but does not interfere with daily activities, Grade 2: interferes with daily activities, Grade 3: prevents daily activities.
Outcome measures
| Measure |
CYD Dengue Vaccine 5555 Formulation
n=101 Participants
Participants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 5553 Formulation
n=101 Participants
Participants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 4444 Formulation
n=53 Participants
Participants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
|---|---|---|---|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Fever
|
14 Participants
|
20 Participants
|
6 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Fever: Grade 1
|
11 Participants
|
18 Participants
|
3 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Fever: Grade 2
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Fever: Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Headache
|
58 Participants
|
59 Participants
|
28 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Headache: Grade 1
|
28 Participants
|
38 Participants
|
16 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Headache: Grade 2
|
24 Participants
|
18 Participants
|
9 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Headache: Grade 3
|
6 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Malaise
|
39 Participants
|
43 Participants
|
14 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Malaise: Grade 1
|
16 Participants
|
26 Participants
|
9 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Malaise: Grade 2
|
19 Participants
|
12 Participants
|
5 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Malaise: Grade 3
|
4 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Myalgia
|
43 Participants
|
49 Participants
|
18 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Myalgia: Grade 1
|
29 Participants
|
30 Participants
|
10 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Myalgia: Grade 2
|
10 Participants
|
17 Participants
|
7 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Myalgia: Grade 3
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Asthenia
|
29 Participants
|
32 Participants
|
12 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Asthenia: Grade 1
|
18 Participants
|
17 Participants
|
9 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Asthenia: Grade 2
|
8 Participants
|
14 Participants
|
3 Participants
|
|
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Asthenia: Grade 3
|
3 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 7 days post-injection 1 and 2, 14 days post-injection 1 and 2Population: Analysis was performed on Viremia Analysis Set which included all participants who received study vaccination and provided at least one blood sample for which vaccine viremia laboratory results were available. Here, 'number analyzed' = participants with available data for each specified category.
Vaccine viremia (level of vaccine virus in blood samples taken from participants) was measured by an assay yellow fever reverse transcriptase polymerase chain reaction which allowed the detection of vaccine viremia of any serotype (1, 2, 3 and 4).
Outcome measures
| Measure |
CYD Dengue Vaccine 5555 Formulation
n=26 Participants
Participants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 5553 Formulation
n=26 Participants
Participants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 4444 Formulation
n=26 Participants
Participants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
|---|---|---|---|
|
Number of Participants With Vaccine Viremia
Vaccine viremia 7 days post-injection 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vaccine Viremia
Vaccine viremia 14 days post-injection 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vaccine Viremia
Vaccine viremia 7 days post-injection 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vaccine Viremia
Vaccine viremia 14 days post-injection 2
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
CYD Dengue Vaccine 5555 Formulation
Serious events: 3 serious events
Other events: 78 other events
Deaths: 0 deaths
CYD Dengue Vaccine 5553 Formulation
Serious events: 3 serious events
Other events: 82 other events
Deaths: 0 deaths
CYD Dengue Vaccine 4444 Formulation
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CYD Dengue Vaccine 5555 Formulation
n=101 participants at risk
Participants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 5553 Formulation
n=101 participants at risk
Participants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 4444 Formulation
n=53 participants at risk
Participants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Pancreatic Neoplasm
|
0.99%
1/101 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/101 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/53 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.99%
1/101 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/101 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/53 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/101 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
0.99%
1/101 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/53 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
|
Nervous system disorders
Optic Neuritis
|
0.99%
1/101 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/101 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/53 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/101 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
2.0%
2/101 • Number of events 2 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/53 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
|
Psychiatric disorders
Post-Traumatic Stress Disorder
|
0.00%
0/101 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/101 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
1.9%
1/53 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/101 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
0.00%
0/101 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
1.9%
1/53 • Number of events 1 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
Other adverse events
| Measure |
CYD Dengue Vaccine 5555 Formulation
n=101 participants at risk
Participants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 5553 Formulation
n=101 participants at risk
Participants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
CYD Dengue Vaccine 4444 Formulation
n=53 participants at risk
Participants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months.
|
|---|---|---|---|
|
General disorders
Asthenia
|
28.7%
29/101 • Number of events 38 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
31.7%
32/101 • Number of events 41 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
22.6%
12/53 • Number of events 14 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
|
General disorders
Injection Site Erythema
|
25.7%
26/101 • Number of events 36 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
26.7%
27/101 • Number of events 34 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
15.1%
8/53 • Number of events 11 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
|
General disorders
Injection Site Pain
|
49.5%
50/101 • Number of events 73 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
41.6%
42/101 • Number of events 64 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
30.2%
16/53 • Number of events 21 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
|
General disorders
Injection Site Swelling
|
18.8%
19/101 • Number of events 23 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
13.9%
14/101 • Number of events 14 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
5.7%
3/53 • Number of events 4 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
|
General disorders
Malaise
|
38.6%
39/101 • Number of events 63 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
42.6%
43/101 • 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 or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
26.4%
14/53 • Number of events 17 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
|
General disorders
Pyrexia
|
13.9%
14/101 • Number of events 17 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
20.8%
21/101 • Number of events 25 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
11.3%
6/53 • Number of events 8 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.9%
6/101 • Number of events 6 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
6.9%
7/101 • Number of events 7 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
3.8%
2/53 • Number of events 2 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
42.6%
43/101 • Number of events 68 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
49.5%
50/101 • Number of events 72 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
34.0%
18/53 • Number of events 21 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
|
Nervous system disorders
Headache
|
58.4%
59/101 • Number of events 104 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
59.4%
60/101 • Number of events 94 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
52.8%
28/53 • Number of events 39 • Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 6 months after last vaccination (up to 18 months).
Analysis was performed on Safety Analysis Set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER