Trial Outcomes & Findings for Study of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India (NCT NCT01550289)
NCT ID: NCT01550289
Last Updated: 2022-04-05
Results Overview
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
189 participants
Primary outcome timeframe
Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Results posted on
2022-04-05
Participant Flow
Study participants were enrolled from 27 March 2012 to 28 June 2012 at 5 clinical centers in India.
A total of 189 participants who met all inclusion and no exclusion criteria were randomized and vaccinated in this trial; 187 were included in the Full Analysis Set.
Participant milestones
| Measure |
CYD Dengue Vaccine Group
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
|
Placebo Group
Healthy adult participants received 3 vaccinations of placebo vaccine.
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
61
|
|
Overall Study
COMPLETED
|
115
|
57
|
|
Overall Study
NOT COMPLETED
|
13
|
4
|
Reasons for withdrawal
| Measure |
CYD Dengue Vaccine Group
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
|
Placebo Group
Healthy adult participants received 3 vaccinations of placebo vaccine.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
11
|
3
|
Baseline Characteristics
Study of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India
Baseline characteristics by cohort
| Measure |
CYD Dengue Vaccine Group
n=126 Participants
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
|
Placebo Group
n=61 Participants
Healthy adult participants received 3 vaccinations of placebo vaccine.
|
Total
n=187 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
|
|
Age, Categorical
Between 18 and 65 years
|
126 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29.5 Years
STANDARD_DEVIATION 7.17 • n=5 Participants
|
29.6 Years
STANDARD_DEVIATION 6.41 • n=7 Participants
|
29.5 Years
STANDARD_DEVIATION 6.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
126 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)Population: Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=126 Participants
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
|
Placebo Group
n=61 Participants
Healthy adult participants received 3 vaccinations of placebo vaccine.
|
|---|---|---|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Pre-injection 1 (N=126, 61)
|
83.3 Percentage of participants
|
80.3 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-injection 1 (N=125, 61)
|
91.2 Percentage of participants
|
83.6 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-injection 2 (N=117, 58)
|
94.9 Percentage of participants
|
81.0 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-injection 3 (N=115, 57)
|
97.4 Percentage of participants
|
87.7 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Pre-injection 1 (N=126, 61)
|
83.3 Percentage of participants
|
86.9 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-injection 1 (N=126, 61)
|
94.4 Percentage of participants
|
88.5 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-injection 2 (N=117, 58)
|
99.1 Percentage of participants
|
84.5 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-injection 3 (N=115, 57)
|
97.4 Percentage of participants
|
91.2 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Pre-injection 1 (N=126, 61)
|
84.9 Percentage of participants
|
86.9 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-injection 1 (N=126, 61)
|
98.4 Percentage of participants
|
90.2 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-injection 2 (N=117, 58)
|
98.3 Percentage of participants
|
84.5 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-injection 3 (N=115, 57)
|
99.1 Percentage of participants
|
89.5 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Pre-injection 1 (N=126, 61)
|
77.0 Percentage of participants
|
80.3 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-injection 1 (N=126, 61)
|
96.0 Percentage of participants
|
85.2 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-injection 2 (N=117, 57)
|
99.1 Percentage of participants
|
78.9 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-injection 3 (N=115, 57)
|
100.0 Percentage of participants
|
84.2 Percentage of participants
|
PRIMARY outcome
Timeframe: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)Population: Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=126 Participants
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
|
Placebo Group
n=61 Participants
Healthy adult participants received 3 vaccinations of placebo vaccine.
|
|---|---|---|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
At least 1 serotype; Pre-injection 1 (N=126, 61)
|
86.5 Percentage of participants
|
88.5 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
At least 1 serotype; Post-injection 1 (N=126, 61)
|
99.2 Percentage of participants
|
90.2 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
At least 1 serotype; Post-injection 2 (N=117, 58)
|
100.0 Percentage of participants
|
86.2 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
At least 1 serotype; Post-injection 3 (N=115, 57)
|
100.0 Percentage of participants
|
91.2 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
At least 2 serotypes; Pre-injection 1 (N=126, 61)
|
84.1 Percentage of participants
|
85.2 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
At least 2 serotypes; Post-injection 1 (N=126, 61)
|
98.4 Percentage of participants
|
88.5 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
At least 2 serotypes; Post-injection 2 (N=117, 58)
|
98.3 Percentage of participants
|
82.8 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
At least 2 serotypes; Post-injection 3 (N=115, 57)
|
99.1 Percentage of participants
|
89.5 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
At least 3 serotypes; Pre-injection 1 (N=126, 61)
|
82.5 Percentage of participants
|
83.6 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
At least 3 serotypes; Post-injection 1 (N=126, 61)
|
92.1 Percentage of participants
|
88.5 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
At least 3 serotypes; Post-injection 2 (N=117, 58)
|
98.3 Percentage of participants
|
81.0 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
At least 3 serotypes; Post-injection 3 (N=115, 57)
|
97.4 Percentage of participants
|
87.7 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
All 4 serotypes; Pre-injection 1 (N=126, 61)
|
75.4 Percentage of participants
|
77.0 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
All 4 serotypes; Post-injection 1 (N=126, 61)
|
89.7 Percentage of participants
|
80.3 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
All 4 serotypes; Post-injection 2 (N=117, 58)
|
94.9 Percentage of participants
|
77.6 Percentage of participants
|
|
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
All 4 serotypes; Post-injection 3 (N=115, 57)
|
97.4 Percentage of participants
|
84.2 Percentage of participants
|
PRIMARY outcome
Timeframe: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)Population: Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=126 Participants
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
|
Placebo Group
n=61 Participants
Healthy adult participants received 3 vaccinations of placebo vaccine.
|
|---|---|---|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Pre-injection 1 (N=126, 61)
|
184 Titers (1/dilutions)
Interval 127.0 to 268.0
|
234 Titers (1/dilutions)
Interval 133.0 to 409.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-injection 1 (N=125, 61)
|
605 Titers (1/dilutions)
Interval 410.0 to 892.0
|
288 Titers (1/dilutions)
Interval 161.0 to 513.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-injection 2 (N=117, 58)
|
556 Titers (1/dilutions)
Interval 391.0 to 790.0
|
294 Titers (1/dilutions)
Interval 159.0 to 543.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-injection 3 (N=115, 57)
|
461 Titers (1/dilutions)
Interval 340.0 to 625.0
|
268 Titers (1/dilutions)
Interval 164.0 to 438.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Pre-injection 1 (N=126, 61)
|
204 Titers (1/dilutions)
Interval 141.0 to 294.0
|
243 Titers (1/dilutions)
Interval 147.0 to 403.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-injection 1 (N=126, 61)
|
720 Titers (1/dilutions)
Interval 510.0 to 1015.0
|
300 Titers (1/dilutions)
Interval 184.0 to 489.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-injection 2 (N=117, 58)
|
787 Titers (1/dilutions)
Interval 592.0 to 1045.0
|
288 Titers (1/dilutions)
Interval 163.0 to 509.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-injection 3 (N=115, 57)
|
484 Titers (1/dilutions)
Interval 370.0 to 634.0
|
258 Titers (1/dilutions)
Interval 163.0 to 410.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Pre-injection 1 (N=126, 61)
|
219 Titers (1/dilutions)
Interval 153.0 to 312.0
|
216 Titers (1/dilutions)
Interval 131.0 to 354.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-injection 1 (N=126, 61)
|
951 Titers (1/dilutions)
Interval 691.0 to 1309.0
|
293 Titers (1/dilutions)
Interval 180.0 to 478.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-injection 2 (N=117, 58)
|
846 Titers (1/dilutions)
Interval 635.0 to 1127.0
|
249 Titers (1/dilutions)
Interval 143.0 to 434.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-injection 3 (N=115, 57)
|
709 Titers (1/dilutions)
Interval 552.0 to 911.0
|
268 Titers (1/dilutions)
Interval 168.0 to 426.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Pre injection 1 (N=126, 61)
|
55.4 Titers (1/dilutions)
Interval 41.4 to 74.2
|
62.0 Titers (1/dilutions)
Interval 42.0 to 91.5
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-injection 1 (N=126, 61)
|
358 Titers (1/dilutions)
Interval 271.0 to 472.0
|
78.7 Titers (1/dilutions)
Interval 52.7 to 117.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-injection 2 (N=117, 57)
|
289 Titers (1/dilutions)
Interval 236.0 to 354.0
|
72.8 Titers (1/dilutions)
Interval 46.6 to 114.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-injection 3 (N=115, 57)
|
336 Titers (1/dilutions)
Interval 271.0 to 417.0
|
91.9 Titers (1/dilutions)
Interval 60.8 to 139.0
|
PRIMARY outcome
Timeframe: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)Population: Geometric mean titer ratios were assessed in the Full Analysis Set with available data for each time point.
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=126 Participants
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
|
Placebo Group
n=61 Participants
Healthy adult participants received 3 vaccinations of placebo vaccine.
|
|---|---|---|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-inj. 1/Pre-inj. 1 (N=126,61)
|
6.46 Titer ratio
Interval 4.74 to 8.79
|
1.27 Titer ratio
Interval 1.0 to 1.61
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-inj. 2/Pre-inj. 1 (N=117,57)
|
5.16 Titer ratio
Interval 3.98 to 6.68
|
1.15 Titer ratio
Interval 0.92 to 1.45
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-inj. 3/Pre-inj. 1 (N=115,57)
|
6.11 Titer ratio
Interval 4.81 to 7.77
|
1.44 Titer ratio
Interval 1.09 to 1.9
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-inj. 1/Pre-inj. 1 (N=125,61)
|
3.23 Titer ratio
Interval 2.49 to 4.18
|
1.23 Titer ratio
Interval 1.02 to 1.49
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-inj. 2/Pre-inj. 1 (N=117,58)
|
3.15 Titer ratio
Interval 2.46 to 4.04
|
1.26 Titer ratio
Interval 1.01 to 1.58
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-inj. 3/Pre-inj. 1 (N=115,57)
|
2.64 Titer ratio
Interval 2.08 to 3.35
|
1.18 Titer ratio
Interval 0.838 to 1.66
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-inj. 1/Pre-inj. 1 (N=126,61)
|
3.53 Titer ratio
Interval 2.76 to 4.52
|
1.23 Titer ratio
Interval 1.03 to 1.47
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-inj. 2/Pre-inj. 1 (N=117,58)
|
3.83 Titer ratio
Interval 2.84 to 5.18
|
1.17 Titer ratio
Interval 0.951 to 1.45
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-inj. 3/Pre-inj. 1 (N=115,57)
|
2.38 Titer ratio
Interval 1.81 to 3.11
|
1.05 Titer ratio
Interval 0.791 to 1.41
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-inj. 1/Pre-inj. 1 (N=126,61)
|
4.35 Titer ratio
Interval 3.34 to 5.68
|
1.36 Titer ratio
Interval 1.09 to 1.69
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-inj. 2/Pre-inj. 1 (N=117,58)
|
3.97 Titer ratio
Interval 2.99 to 5.28
|
1.13 Titer ratio
Interval 0.888 to 1.44
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-inj. 3/Pre-inj. 1 (N=115,57)
|
3.39 Titer ratio
Interval 2.61 to 4.4
|
1.22 Titer ratio
Interval 0.869 to 1.72
|
PRIMARY outcome
Timeframe: Day 0 up to Day 14 post each injectionPopulation: Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set with available data for each time point.
Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain Significant; prevents daily activities; Erythema and Swelling \>100 mm. Grade 3 Solicited systemic reactions: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Asthenia Significant; prevents daily activities.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=127 Participants
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
|
Placebo Group
n=61 Participants
Healthy adult participants received 3 vaccinations of placebo vaccine.
|
|---|---|---|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Injection-site Pain; Post-Any inj. (N=126, 61)
|
9.5 Percentage of participants
|
4.9 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Inj.-site Pain; Post-Any inj. (N=126, 61)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Injection-site Erythema; Post-Any inj. (N=126, 61)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Inj.-site Erythema;Post-Any inj (N=126,61)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Injection-site Swelling; Post-Any inj. (N=126, 61)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Inj.-site Swelling;PostAny inj (N=126,61)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Injection-site Pain; Post-inj. 1 (N=126, 61)
|
6.3 Percentage of participants
|
4.9 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Inj.-site Pain; Post-inj. 1 (N=126, 61)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Injection-site Erythema; Post-inj. 1 (N=126, 61)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Inj.-site Erythema; Post-inj 1 (N=126,61)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Injection-site Swelling; Post-inj. 1 (N=126, 61)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Inj.-site Swelling; Post-inj. 1 (N=126,61)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Injection-site Pain; Post-inj. 2 (N=117, 58)
|
1.7 Percentage of participants
|
3.4 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Inj.-site Pain; Post-inj. 2 (N=117, 58)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Injection-site Erythema; Post-inj. 2 (N=117, 58)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Inj.-site Erythema; Post-inj 2 (N=117,58)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Injection-site Swelling; Post-inj. 2 (N=117, 58)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Fever; Post-Any inj. (N=126, 61)
|
0.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Inj.-site Swelling; Post-inj. 2 (N=117,58)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Injection-site Pain; Post-inj. 3 (N=115, 57)
|
2.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Inj.-site Pain; Post-inj. 3 (N=115, 57)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Injection-site Erythema; Post-inj. 3 (N=115, 57)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Inj.-site Erythema; Post-inj 3 (N=115,57)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Injection-site Swelling; Post-inj. 3 (N=115, 57)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Inj.-site Swelling; Post-inj. 3 (N=115,57)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Fever; Post-Any inj. (N=126, 61)
|
5.6 Percentage of participants
|
1.6 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Headache; Post Any\-inj. (N=126, 61)
|
7.9 Percentage of participants
|
4.9 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Asthenia; Post-inj. 1 (N=126, 61)
|
9.5 Percentage of participants
|
4.9 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Headache; Post-Any inj. (N=126, 61)
|
1.6 Percentage of participants
|
1.6 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Malaise; Post-Any inj. (N=126, 61)
|
8.7 Percentage of participants
|
4.9 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Malaise; Post-Any inj. (N=126, 61)
|
0.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Myalgia; Post Any inj. (N=126, 61)
|
9.5 Percentage of participants
|
4.9 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Myalgia; Post-Any inj. (N=126, 61)
|
0.0 Percentage of participants
|
1.6 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Asthenia; Post-Any inj. (N=126, 61)
|
11.1 Percentage of participants
|
4.9 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Asthenia; Post-Any inj. (N=126, 61)
|
0.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Fever; Post-inj. 1 (N=125, 60)
|
4.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Fever; Post-inj. 1 (N=125, 60)
|
0.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Headache; Post-inj. 1 (N=126, 61)
|
5.6 Percentage of participants
|
4.9 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Headache; Post-inj. 1 (N=126, 61)
|
1.6 Percentage of participants
|
1.6 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Malaise; Post-inj. 1 (N=126, 61)
|
7.1 Percentage of participants
|
4.9 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Malaise; Post-inj. 1 (N=126, 61)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Myalgia; Post-inj. 1 (N=126, 61)
|
7.9 Percentage of participants
|
4.9 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Myalgia; Post inj. 1 (N=126, 61)
|
0 Percentage of participants
|
1.6 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Asthenia; Post inj. 1 (N=126, 61)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Fever; Post-inj. 2 (N=117, 58)
|
0.9 Percentage of participants
|
1.7 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Fever; Post-inj. 2 (N=117, 58)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Headache; Post-inj. 2 (N=117, 58)
|
1.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Headache; Post-inj. 2 (N=117, 58)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Malaise; Post-inj. 2 (N=117, 58)
|
0.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Malaise; Post-inj. 2 (N=117, 58)
|
0.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Myalgia; Post-inj. 2 (N=117, 58)
|
1.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Myalgia; Post-inj. 2 (N=117, 58)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Asthenia; Post-inj. 2 (N=117, 58)
|
2.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Asthenia; Post-inj. 2 (N=117, 58)
|
0.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Fever; Post-inj. 3 (N=113, 57)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Fever; Post inj. 3 (N=113, 57)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Headache; Post-inj. 3 (N=115, 57)
|
0.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Headache; Post-inj. 3 (N=115, 57)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Malaise; Post-inj. 3 (N=115, 57)
|
0.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Malaise; Post-inj. 3 (N=115, 57)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Myalgia; Post-inj. 3 (N=115, 57)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Myalgia; Post-inj. 3 (N=115, 57)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Asthenia; Post-inj. 3 (N=115, 57)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Grade 3 Asthenia; Post-inj. 3 (N=115, 57)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)Population: Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=113 Participants
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
|
Placebo Group
n=56 Participants
Healthy adult participants received 3 vaccinations of placebo vaccine.
|
|---|---|---|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Pre-injection 1 (N=113, 56)
|
92.9 Percentage of participants
|
87.5 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-injection 1 (N=112, 56)
|
96.4 Percentage of participants
|
89.3 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-injection 2 (N=104, 53)
|
99.0 Percentage of participants
|
88.7 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-injection 3 (N=102, 52)
|
100.0 Percentage of participants
|
94.2 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Pre-injection 1 (N=113, 56)
|
92.9 Percentage of participants
|
94.6 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-injection 1 (N=113, 56)
|
98.2 Percentage of participants
|
94.6 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-injection 2 (N=104, 53)
|
100.0 Percentage of participants
|
92.5 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-injection 3 (N=102, 52)
|
100.0 Percentage of participants
|
98.1 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Pre-injection 1 (N=113, 56)
|
94.7 Percentage of participants
|
94.6 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-injection 1 (N=113, 56)
|
100.0 Percentage of participants
|
96.4 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-injection 2 (N=104, 53)
|
100.0 Percentage of participants
|
92.5 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-injection 3 (N=102, 52)
|
100.0 Percentage of participants
|
96.2 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Pre-injection 1 (N=113, 56)
|
85.8 Percentage of participants
|
87.5 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-injection 1 (N=113, 56)
|
98.2 Percentage of participants
|
91.1 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-injection 2 (N=104, 52)
|
100.0 Percentage of participants
|
86.5 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-injection 3 (N=102, 52)
|
100.0 Percentage of participants
|
90.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)Population: Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non-immune participants at baseline are defined as those participants with \<10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=13 Participants
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
|
Placebo Group
n=5 Participants
Healthy adult participants received 3 vaccinations of placebo vaccine.
|
|---|---|---|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-injection 3 (N=13, 5)
|
100.0 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Pre-injection 1 (N=13, 5)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-injection 1 (N=13, 5)
|
46.2 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-injection 2 (N=13, 5)
|
61.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-injection 3 (N=13, 5)
|
76.9 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Pre-injection 1 (N=13, 5)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-injection 1 (N=13, 5)
|
61.5 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-injection 2 (N=13, 5)
|
92.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post injection 3 (N=13, 5)
|
76.9 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Pre-injection 1 (N=13, 5)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-injection 1 (N=13, 5)
|
84.6 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-injection 2 (N=13, 5)
|
84.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-injection 3 (N=13, 5)
|
92.3 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Pre-injection 1 (N=13, 5)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-injection 1 (N=13, 5)
|
76.9 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-injection 2 (N=13, 5)
|
92.3 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)Population: Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=113 Participants
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
|
Placebo Group
n=56 Participants
Healthy adult participants received 3 vaccinations of placebo vaccine.
|
|---|---|---|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 2 serotypes; Post-injection 2 (N=104, 53)
|
100.0 Percentage of participants
|
90.6 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 2 serotypes; Post-injection 3 (N=102, 52)
|
100.0 Percentage of participants
|
96.2 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 3 serotypes; Pre-injection 1 (N=113, 56)
|
92.0 Percentage of participants
|
91.1 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 3 serotypes; Post-injection 1 (N=113, 56)
|
96.5 Percentage of participants
|
94.6 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 3 serotypes; Post-injection 2 (N=104, 53)
|
100.0 Percentage of participants
|
88.7 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 3 serotypes; Post-injection 3 (N=102, 52)
|
100.0 Percentage of participants
|
94.2 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
All 4 serotypes; Pre-injection 1 (N=113, 56)
|
84.1 Percentage of participants
|
83.9 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
All 4 serotypes; Post-injection 1 (N=113, 56)
|
95.6 Percentage of participants
|
85.7 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
All 4 serotypes; Post-injection 2 (N=104, 53)
|
99.0 Percentage of participants
|
84.9 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
All 4 serotypes; Post-injection 3 (N=102, 52)
|
100.0 Percentage of participants
|
90.4 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 1 serotype; Pre-injection 1 (N=113, 56)
|
96.5 Percentage of participants
|
96.4 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 1 serotype; Post-injection 1 (N=113, 56)
|
100.0 Percentage of participants
|
96.4 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 1 serotype; Post-injection 2 (N=104, 53)
|
100.0 Percentage of participants
|
94.3 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 1 serotype; Post-injection 3 (N=102, 52)
|
100.0 Percentage of participants
|
98.1 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 2 serotypes; Pre-injection 1 (N=113, 56)
|
93.8 Percentage of participants
|
92.9 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 2 serotypes; Post-injection 1 (N=113, 56)
|
100.0 Percentage of participants
|
94.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)Population: Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with \<10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=13 Participants
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
|
Placebo Group
n=5 Participants
Healthy adult participants received 3 vaccinations of placebo vaccine.
|
|---|---|---|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 2 serotypes; Post-injection 2 (N=13, 5)
|
84.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 1 serotype; Pre-injection 1 (N=13, 5)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 1 serotype; Post-injection 1 (N=13, 5)
|
92.3 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 1 serotype; Post-injection 2 (N=13, 5)
|
100.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 1 serotype; Post-injection 3 (N=13, 5)
|
100.0 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 2 serotypes; Pre-injection 1 (N=13, 5)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 2 serotypes; Post-injection 1 (N=13, 5)
|
84.6 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 2 serotypes; Post-injection 3 (N=13, 5)
|
92.3 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 3 serotypes; Pre-injection 1 (N=13, 5)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 3 serotypes; Post-injection 1 (N=13, 5)
|
53.8 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 3 serotypes; Post-injection 2 (N=13, 5)
|
84.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
At least 3 serotypes; Post-injection 3 (N=13, 5)
|
76.9 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
All 4 serotypes; Pre-injection 1 (N=13, 5)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
All 4 serotypes; Post-injection 1 (N=13, 5)
|
38.5 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
All 4 serotypes; Post-injection 2 (N=13, 5)
|
61.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
All 4 serotypes; Post-injection 3 (N=13, 5)
|
76.9 Percentage of participants
|
20.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)Population: Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=113 Participants
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
|
Placebo Group
n=56 Participants
Healthy adult participants received 3 vaccinations of placebo vaccine.
|
|---|---|---|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Pre-injection 1 (N=113, 56)
|
279 Titers (1/dilutions)
Interval 199.0 to 392.0
|
329 Titers (1/dilutions)
Interval 196.0 to 553.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-injection 1 (N=112, 56)
|
925 Titers (1/dilutions)
Interval 656.0 to 1304.0
|
401 Titers (1/dilutions)
Interval 232.0 to 691.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-injection 2 (N=104, 53)
|
807 Titers (1/dilutions)
Interval 591.0 to 1101.0
|
432 Titers (1/dilutions)
Interval 245.0 to 760.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-injection 3 (N=102, 52)
|
636 Titers (1/dilutions)
Interval 485.0 to 834.0
|
362 Titers (1/dilutions)
Interval 235.0 to 558.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Pre-injection 1 (N=113, 56)
|
312 Titers (1/dilutions)
Interval 225.0 to 432.0
|
344 Titers (1/dilutions)
Interval 221.0 to 537.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-injection 1 (N=113, 56)
|
1030 Titers (1/dilutions)
Interval 765.0 to 1385.0
|
413 Titers (1/dilutions)
Interval 268.0 to 636.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-injection 2 (N=104, 53)
|
1010 Titers (1/dilutions)
Interval 792.0 to 1288.0
|
422 Titers (1/dilutions)
Interval 254.0 to 702.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-injection 3 (N=102, 52)
|
624 Titers (1/dilutions)
Interval 493.0 to 790.0
|
357 Titers (1/dilutions)
Interval 242.0 to 528.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Pre-injection 1 (N=113, 56)
|
338 Titers (1/dilutions)
Interval 249.0 to 458.0
|
302 Titers (1/dilutions)
Interval 195.0 to 469.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-injection 1 (N=113, 56)
|
1324 Titers (1/dilutions)
Interval 1002.0 to 1749.0
|
405 Titers (1/dilutions)
Interval 263.0 to 623.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-injection 2 (N=104, 53)
|
1131 Titers (1/dilutions)
Interval 879.0 to 1455.0
|
361 Titers (1/dilutions)
Interval 219.0 to 594.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-injection 3 (N=102, 52)
|
912 Titers (1/dilutions)
Interval 726.0 to 1145.0
|
368 Titers (1/dilutions)
Interval 248.0 to 547.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Pre-injection 1 (N=113, 56)
|
73.1 Titers (1/dilutions)
Interval 55.1 to 96.9
|
77.6 Titers (1/dilutions)
Interval 53.6 to 112.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-injection 1 (N=113, 56)
|
424 Titers (1/dilutions)
Interval 325.0 to 554.0
|
99.1 Titers (1/dilutions)
Interval 67.8 to 145.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-injection 2 (N=104, 52)
|
346 Titers (1/dilutions)
Interval 287.0 to 417.0
|
94.2 Titers (1/dilutions)
Interval 61.6 to 144.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-injection 3 (N=102, 52)
|
387 Titers (1/dilutions)
Interval 309.0 to 485.0
|
117 Titers (1/dilutions)
Interval 79.7 to 172.0
|
SECONDARY outcome
Timeframe: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)Population: Geometric mean titers ratios were assessed in the Full Analysis Set with available data for each time point.
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=113 Participants
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
|
Placebo Group
n=56 Participants
Healthy adult participants received 3 vaccinations of placebo vaccine.
|
|---|---|---|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-inj. 1/Pre-inj. 1 (N=112,56)
|
3.24 Titer ratio
Interval 2.47 to 4.25
|
1.22 Titer ratio
Interval 0.994 to 1.49
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-inj. 2/Pre-inj. 1 (N=104,53)
|
2.93 Titer ratio
Interval 2.28 to 3.77
|
1.29 Titer ratio
Interval 1.01 to 1.65
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-inj. 3/Pre-inj. 1 (N=102,52)
|
2.31 Titer ratio
Interval 1.82 to 2.94
|
1.10 Titer ratio
Interval 0.786 to 1.55
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-inj. 1/Pre-inj. 1 (N=113,56)
|
3.30 Titer ratio
Interval 2.59 to 4.2
|
1.20 Titer ratio
Interval 1.01 to 1.43
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-inj. 2/Pre-inj. 1 (N=104,53)
|
3.09 Titer ratio
Interval 2.34 to 4.08
|
1.19 Titer ratio
Interval 0.946 to 1.5
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-inj. 3/Pre-inj. 1 (N=102,52)
|
1.91 Titer ratio
Interval 1.49 to 2.45
|
1.00 Titer ratio
Interval 0.746 to 1.35
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-inj. 1/Pre-inj. 1 (N=113,56)
|
3.92 Titer ratio
Interval 3.0 to 5.13
|
1.34 Titer ratio
Interval 1.07 to 1.69
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-inj. 2/Pre-inj. 1 (N=104,53)
|
3.32 Titer ratio
Interval 2.5 to 4.41
|
1.15 Titer ratio
Interval 0.878 to 1.5
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-inj. 3/Pre-inj. 1 (N=102,52)
|
2.71 Titer ratio
Interval 2.1 to 3.49
|
1.17 Titer ratio
Interval 0.82 to 1.67
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-inj. 1/Pre-inj. 1 (N=113,56)
|
5.80 Titer ratio
Interval 4.23 to 7.96
|
1.28 Titer ratio
Interval 0.988 to 1.65
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-inj. 2/Pre-inj. 1 (N=104,52)
|
4.86 Titer ratio
Interval 3.48 to 5.99
|
1.17 Titer ratio
Interval 0.912 to 1.5
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-inj. 3/Pre-inj. 1 (N=102,52)
|
5.18 Titer ratio
Interval 4.03 to 6.66
|
1.43 Titer ratio
Interval 1.06 to 1.93
|
SECONDARY outcome
Timeframe: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)Population: Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with \<10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=13 Participants
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
|
Placebo Group
n=5 Participants
Healthy adult participants received 3 vaccinations of placebo vaccine.
|
|---|---|---|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Pre-injection 1 (N=13, 5)
|
5.00 Titers (1/dilutions)
Interval 5.0 to 5.0
|
5.00 Titers (1/dilutions)
Interval 5.0 to 5.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-injection 1 (N=13, 5)
|
15.5 Titers (1/dilutions)
Interval 5.83 to 41.3
|
7.01 Titers (1/dilutions)
Interval 2.75 to 17.9
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-injection 2 (N=13, 5)
|
28.2 Titers (1/dilutions)
Interval 9.88 to 80.4
|
5.00 Titers (1/dilutions)
Interval 5.0 to 5.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-injection 3 (N=13, 5)
|
37.1 Titers (1/dilutions)
Interval 16.0 to 86.5
|
11.8 Titers (1/dilutions)
Interval 1.09 to 126.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Pre-injection 1 (N=13, 5)
|
5.00 Titers (1/dilutions)
Interval 5.0 to 5.0
|
5.00 Titers (1/dilutions)
Interval 5.0 to 5.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-injection 1 (N=13, 5)
|
32.1 Titers (1/dilutions)
Interval 9.14 to 112.0
|
8.27 Titers (1/dilutions)
Interval 2.04 to 33.5
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-injection 2 (N=13, 5)
|
107 Titers (1/dilutions)
Interval 27.9 to 410.0
|
5.00 Titers (1/dilutions)
Interval 5.0 to 5.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-injection 3 (N=13, 5)
|
66.8 Titers (1/dilutions)
Interval 22.8 to 196.0
|
8.93 Titers (1/dilutions)
Interval 1.78 to 44.7
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Pre-injection 1 (N=13, 5)
|
5.00 Titers (1/dilutions)
Interval 5.0 to 5.0
|
5.00 Titers (1/dilutions)
Interval 5.0 to 5.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-injection 1 (N=13, 5)
|
53.8 Titers (1/dilutions)
Interval 17.7 to 163.0
|
5.96 Titers (1/dilutions)
Interval 3.66 to 9.69
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-injection 2 (N=13, 5)
|
83.1 Titers (1/dilutions)
Interval 30.3 to 228.0
|
5.00 Titers (1/dilutions)
Interval 5.0 to 5.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-injection 3 (N=13, 5)
|
98.6 Titers (1/dilutions)
Interval 48.1 to 202.0
|
9.72 Titers (1/dilutions)
Interval 1.53 to 61.6
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Pre-injection 1 (N=13, 5)
|
5.00 Titers (1/dilutions)
Interval 5.0 to 5.0
|
5.00 Titers (1/dilutions)
Interval 5.0 to 5.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-injection 1 (N=13, 5)
|
81.8 Titers (1/dilutions)
Interval 25.0 to 267.0
|
5.96 Titers (1/dilutions)
Interval 3.66 to 9.69
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-injection 2 (N=13, 5)
|
68.4 Titers (1/dilutions)
Interval 33.3 to 141.0
|
5.00 Titers (1/dilutions)
Interval 5.0 to 5.0
|
|
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-injection 3 (N=13, 5)
|
111 Titers (1/dilutions)
Interval 79.9 to 155.0
|
7.29 Titers (1/dilutions)
Interval 2.56 to 20.8
|
SECONDARY outcome
Timeframe: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)Population: Geometric mean titers ratios were assessed in the Full Analysis Set with available data for each time point.
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=13 Participants
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
|
Placebo Group
n=5 Participants
Healthy adult participants received 3 vaccinations of placebo vaccine.
|
|---|---|---|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-inj. 1/Pre-inj. 1 (N=13,5)
|
3.10 Titer ratio
Interval 1.17 to 8.25
|
1.40 Titer ratio
Interval 0.549 to 3.57
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-inj. 2/Pre-inj. 1 (N=13,5)
|
5.64 Titer ratio
Interval 1.98 to 16.1
|
1.00 Titer ratio
Interval 1.0 to 1.0
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 1; Post-inj. 3/Pre-inj. 1 (N=13,5)
|
7.43 Titer ratio
Interval 3.19 to 17.3
|
2.35 Titer ratio
Interval 0.219 to 25.3
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-inj. 1/Pre-inj. 1 (N=13,5)
|
6.41 Titer ratio
Interval 1.83 to 22.5
|
1.65 Titer ratio
Interval 0.409 to 6.7
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-inj. 2/Pre-inj. 1 (N=13,5)
|
21.4 Titer ratio
Interval 5.59 to 81.9
|
1.00 Titer ratio
Interval 1.0 to 1.0
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 2; Post-inj. 3/Pre-inj. 1 (N=13,5)
|
13.4 Titer ratio
Interval 4.56 to 39.1
|
1.79 Titer ratio
Interval 0.357 to 8.95
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-inj. 1/Pre-inj. 1 (N=13,5)
|
10.8 Titer ratio
Interval 3.55 to 32.6
|
1.58 Titer ratio
Interval 0.441 to 5.69
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-inj. 2/Pre-inj. 1 (N=13,5)
|
16.6 Titer ratio
Interval 6.06 to 45.5
|
1.00 Titer ratio
Interval 1.0 to 1.0
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 3; Post-inj. 3/Pre-inj. 1 (N=13,5)
|
19.7 Titer ratio
Interval 9.63 to 40.4
|
1.94 Titer ratio
Interval 0.307 to 12.3
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-inj. 1/Pre-inj. 1 (N=13,5)
|
16.4 Titer ratio
Interval 5.01 to 53.4
|
1.19 Titer ratio
Interval 0.733 to 1.94
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-inj. 2/Pre-inj. 1 (N=13,5)
|
13.7 Titer ratio
Interval 6.66 to 28.1
|
1.00 Titer ratio
Interval 1.0 to 1.0
|
|
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Serotype 4; Post-inj. 3/Pre-inj. 1 (N=13,5)
|
22.2 Titer ratio
Interval 16.0 to 31.0
|
1.46 Titer ratio
Interval 0.511 to 4.16
|
Adverse Events
CYD Dengue Vaccine Group
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo Group
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CYD Dengue Vaccine Group
n=127 participants at risk
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
|
Placebo Group
n=61 participants at risk
Healthy adult participants received 3 vaccinations of placebo vaccine.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia megaloblastic
|
0.79%
1/127 • Number of events 1 • Adverse event data were collected from Day 0 up to 1 year post injection 1.
|
0.00%
0/61 • Adverse event data were collected from Day 0 up to 1 year post injection 1.
|
|
General disorders
Pyrexia
|
0.79%
1/127 • Number of events 1 • Adverse event data were collected from Day 0 up to 1 year post injection 1.
|
0.00%
0/61 • Adverse event data were collected from Day 0 up to 1 year post injection 1.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/127 • Adverse event data were collected from Day 0 up to 1 year post injection 1.
|
1.6%
1/61 • Number of events 1 • Adverse event data were collected from Day 0 up to 1 year post injection 1.
|
Other adverse events
| Measure |
CYD Dengue Vaccine Group
n=127 participants at risk
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
|
Placebo Group
n=61 participants at risk
Healthy adult participants received 3 vaccinations of placebo vaccine.
|
|---|---|---|
|
General disorders
Injection site Pain
|
9.4%
12/127 • Number of events 12 • Adverse event data were collected from Day 0 up to 1 year post injection 1.
|
4.9%
3/61 • Number of events 3 • Adverse event data were collected from Day 0 up to 1 year post injection 1.
|
|
General disorders
Fever
|
5.6%
7/126 • Number of events 7 • Adverse event data were collected from Day 0 up to 1 year post injection 1.
|
1.6%
1/61 • Number of events 1 • Adverse event data were collected from Day 0 up to 1 year post injection 1.
|
|
Nervous system disorders
Headache
|
7.9%
10/126 • Number of events 10 • Adverse event data were collected from Day 0 up to 1 year post injection 1.
|
4.9%
3/61 • Number of events 3 • Adverse event data were collected from Day 0 up to 1 year post injection 1.
|
|
General disorders
Malaise
|
8.7%
11/126 • Number of events 11 • Adverse event data were collected from Day 0 up to 1 year post injection 1.
|
4.9%
3/61 • Number of events 3 • Adverse event data were collected from Day 0 up to 1 year post injection 1.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.5%
12/126 • Number of events 12 • Adverse event data were collected from Day 0 up to 1 year post injection 1.
|
4.9%
3/61 • Number of events 3 • Adverse event data were collected from Day 0 up to 1 year post injection 1.
|
|
General disorders
Asthenia
|
11.1%
14/126 • Number of events 14 • Adverse event data were collected from Day 0 up to 1 year post injection 1.
|
4.9%
3/61 • Number of events 3 • Adverse event data were collected from Day 0 up to 1 year post injection 1.
|
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