Trial Outcomes & Findings for A Phase II Trial of a Live Attenuated Virus Tetravalent Dengue Vaccine in Healthy Adults in Thailand (NCT NCT00370682)
NCT ID: NCT00370682
Last Updated: 2017-05-30
Results Overview
Percentage of subjects with any grade 3 adverse events (AEs) within 21 days follow-up after dose 1 (0 month)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
0-21 days after dose 1
Results posted on
2017-05-30
Participant Flow
A total of 120 subjects were enrolled in study
Participant milestones
| Measure |
T-DEN F17
Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
T-DEN F19
Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
Placebo Comparator
0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
37
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
1
|
Reasons for withdrawal
| Measure |
T-DEN F17
Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
T-DEN F19
Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
Placebo Comparator
0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
|---|---|---|---|
|
Overall Study
Moved from area
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
Baseline Characteristics
A Phase II Trial of a Live Attenuated Virus Tetravalent Dengue Vaccine in Healthy Adults in Thailand
Baseline characteristics by cohort
| Measure |
T-DEN F17
n=40 Participants
Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
T-DEN F19
n=40 Participants
Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
Placebo Comparator
n=40 Participants
0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
21.2 years
STANDARD_DEVIATION 1.09 • n=5 Participants
|
21.7 years
STANDARD_DEVIATION 1.27 • n=7 Participants
|
21.9 years
STANDARD_DEVIATION 1.19 • n=5 Participants
|
21.6 years
STANDARD_DEVIATION 1.21 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - Southeast Asian heritage
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Region of Enrollment
Thailand
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0-21 days after dose 1Percentage of subjects with any grade 3 adverse events (AEs) within 21 days follow-up after dose 1 (0 month)
Outcome measures
| Measure |
T-DEN F17
n=40 Participants
Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
T-DEN F19
n=40 Participants
Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
Placebo Comparator
n=40 Participants
0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
PII (M9)
Post dose 2, Month 9
|
|---|---|---|---|---|
|
Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1
Fever
|
2.5 percentage of subjects
Interval 0.1 to 13.2
|
0.0 percentage of subjects
Interval 0.0 to 9.0
|
2.5 percentage of subjects
Interval 0.1 to 13.2
|
—
|
|
Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1
Vomiting
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
0.0 percentage of subjects
Interval 0.0 to 9.0
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1
Pain
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
0.0 percentage of subjects
Interval 0.0 to 9.0
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1
Redness
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
0.0 percentage of subjects
Interval 0.0 to 9.0
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1
Swelling
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
0.0 percentage of subjects
Interval 0.0 to 9.0
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1
Abdominal Pain
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
0.0 percentage of subjects
Interval 0.0 to 9.0
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1
Arthralgia
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
0.0 percentage of subjects
Interval 0.0 to 9.0
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1
Fatigue
|
2.5 percentage of subjects
Interval 0.1 to 13.2
|
0.0 percentage of subjects
Interval 0.0 to 9.0
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1
Headache
|
2.5 percentage of subjects
Interval 0.1 to 13.2
|
0.0 percentage of subjects
Interval 0.0 to 9.0
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1
Mucsle Aches
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
0.0 percentage of subjects
Interval 0.0 to 9.0
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1
Nausea
|
2.5 percentage of subjects
Interval 0.1 to 13.2
|
0.0 percentage of subjects
Interval 0.0 to 9.0
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1
Pain behind eyes
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
0.0 percentage of subjects
Interval 0.0 to 9.0
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1
Photophobia
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
0.0 percentage of subjects
Interval 0.0 to 9.0
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1
Pruritus
|
2.5 percentage of subjects
Interval 0.1 to 13.2
|
0.0 percentage of subjects
Interval 0.0 to 9.0
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1
Rash
|
5.0 percentage of subjects
Interval 0.6 to 16.9
|
0.0 percentage of subjects
Interval 0.0 to 9.0
|
0.0 percentage of subjects
Interval 0.0 to 8.8
|
—
|
PRIMARY outcome
Timeframe: 30 and 90 days after dose 2Neutralizing antibody geometric mean titer (GMT) to DEN types 1, 2, 3 and 4 will be measured 30 and 90 days following the administration of the 2nd dose (6 month)
Outcome measures
| Measure |
T-DEN F17
n=40 Participants
Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
T-DEN F19
n=40 Participants
Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
Placebo Comparator
n=39 Participants
0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
PII (M9)
n=39 Participants
Post dose 2, Month 9
|
|---|---|---|---|---|
|
Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2
DEN-1, F17
|
172.2 GMTs
Interval 77.0 to 385.5
|
668.7 GMTs
Interval 348.1 to 1284.3
|
958.0 GMTs
Interval 606.5 to 1513.3
|
788.2 GMTs
Interval 461.9 to 1345.2
|
|
Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2
DEN-3, Placebo
|
302.2 GMTs
Interval 154.6 to 591.0
|
289.5 GMTs
Interval 150.3 to 557.8
|
266.0 GMTs
Interval 136.5 to 518.4
|
384.7 GMTs
Interval 207.7 to 712.4
|
|
Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2
DEN-1, F19
|
412.6 GMTs
Interval 205.3 to 829.3
|
1111.8 GMTs
Interval 774.2 to 1596.5
|
1233.4 GMTs
Interval 914.8 to 1663.1
|
1061.1 GMTs
Interval 748.1 to 1505.1
|
|
Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2
DEN-1, Placebo
|
412.9 GMTs
Interval 218.0 to 782.1
|
447.8 GMTs
Interval 234.5 to 855.4
|
441.8 GMTs
Interval 226.1 to 863.5
|
449.2 GMTs
Interval 240.9 to 837.6
|
|
Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2
DEN-2, F17
|
212.5 GMTs
Interval 99.0 to 456.2
|
860.7 GMTs
Interval 493.5 to 1501.3
|
1085.3 GMTs
Interval 803.4 to 1466.0
|
1168.7 GMTs
Interval 842.7 to 1620.9
|
|
Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2
DEN-2, F19
|
278.2 GMTs
Interval 132.2 to 585.6
|
1123.7 GMTs
Interval 762.9 to 1655.0
|
1274.5 GMTs
Interval 946.5 to 1716.4
|
1334.1 GMTs
Interval 1026.4 to 1734.2
|
|
Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2
DEN-2, Placebo
|
180.3 GMTs
Interval 93.1 to 349.1
|
207.4 GMTs
Interval 106.6 to 403.3
|
216.1 GMTs
Interval 109.5 to 426.5
|
231.1 GMTs
Interval 121.1 to 441.0
|
|
Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2
DEN-3, F17
|
117.5 GMTs
Interval 52.7 to 261.8
|
450.2 GMTs
Interval 227.6 to 890.5
|
507.7 GMTs
Interval 288.5 to 893.6
|
519.3 GMTs
Interval 287.2 to 939.0
|
|
Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2
DEN-3, F19
|
241.6 GMTs
Interval 113.9 to 512.6
|
787.9 GMTs
Interval 483.5 to 1283.9
|
836.2 GMTs
Interval 514.0 to 1360.5
|
730.3 GMTs
Interval 425.1 to 1254.6
|
|
Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2
DEN-4, F17
|
113.7 GMTs
Interval 54.6 to 236.7
|
776.3 GMTs
Interval 470.9 to 1279.8
|
745.2 GMTs
Interval 464.5 to 1195.4
|
673.3 GMTs
Interval 419.5 to 1080.7
|
|
Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2
DEN-4, F19
|
149.8 GMTs
Interval 72.9 to 307.7
|
772.4 GMTs
Interval 525.1 to 1136.3
|
695.5 GMTs
Interval 467.0 to 1035.8
|
705.4 GMTs
Interval 472.8 to 1052.4
|
|
Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2
DEN-4, Placebo
|
152.3 GMTs
Interval 80.6 to 287.5
|
158.0 GMTs
Interval 82.9 to 301.0
|
178.7 GMTs
Interval 91.7 to 348.3
|
178.4 GMTs
Interval 93.5 to 340.1
|
SECONDARY outcome
Timeframe: 0-21 days after dose 2 of study vaccinePercentage of subjects with any adverse events (AEs) solicited and unsolicited reported during the 21-day post-vaccination period following dose 2
Outcome measures
| Measure |
T-DEN F17
n=39 Participants
Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
T-DEN F19
n=35 Participants
Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
Placebo Comparator
n=39 Participants
0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
PII (M9)
Post dose 2, Month 9
|
|---|---|---|---|---|
|
Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine
Any symptom
|
74.4 percentage of subjects
Interval 57.9 to 87.0
|
65.7 percentage of subjects
Interval 47.8 to 80.9
|
64.1 percentage of subjects
Interval 47.2 to 78.8
|
—
|
|
Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine
All symptoms
|
51.3 percentage of subjects
Interval 34.8 to 67.6
|
31.4 percentage of subjects
Interval 16.9 to 49.3
|
23.1 percentage of subjects
Interval 11.1 to 39.3
|
—
|
|
Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine
General symptoms
|
71.8 percentage of subjects
Interval 55.1 to 85.0
|
54.3 percentage of subjects
Interval 36.6 to 71.2
|
53.8 percentage of subjects
Interval 37.2 to 69.9
|
—
|
SECONDARY outcome
Timeframe: 0-30 days after each study vaccine doseIncidence of unsolicited AEs reported within the 31-day (Days 0-30) post-vaccination period for each study vaccine
Outcome measures
| Measure |
T-DEN F17
n=40 Participants
Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
T-DEN F19
n=40 Participants
Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
Placebo Comparator
n=40 Participants
0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
PII (M9)
Post dose 2, Month 9
|
|---|---|---|---|---|
|
Incidence of Unsolicited AEs Within 31 Days (Days 0-30) After Any Study Vaccine Dose
|
51 unsolicited AEs
|
34 unsolicited AEs
|
38 unsolicited AEs
|
—
|
SECONDARY outcome
Timeframe: 9 monthsNumber of subjects experiencing serious adverse events (SAEs) throughout the entire 9 month study period
Outcome measures
| Measure |
T-DEN F17
n=40 Participants
Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
T-DEN F19
n=40 Participants
Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
Placebo Comparator
n=40 Participants
0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
PII (M9)
Post dose 2, Month 9
|
|---|---|---|---|---|
|
Incidence of Serious Adverse Events (SAEs) Throughout the Entire Study Period
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: within 31 days after each vaccine doseLaboratory valuesabove the alert values within 31 days (days 0-30) after each vaccine dose. Change from baseline in hematological and biochemical levels with respect to normal ranges. PI(D2, 5, 8, 12) = Post Dose 1, Days 2, 5, 8 and 12 PI(D5, 12,14) = Post Dose 1, Days 5, 12 and 14 PI(M1) = Post Dose 1, Month 1 PI(M6) = Post Dose 1, Month 6 PII(D2, 5, 8, 12) = Post Dose 2, Days 2, 5, 8 and 12 PII(D5, 8, 12, 14) = Post Dose 2, Days 5, 8, 12 and 14 PII(M7) = Post Dose 2, Month 7
Outcome measures
| Measure |
T-DEN F17
n=40 Participants
Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
T-DEN F19
n=40 Participants
Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
Placebo Comparator
n=40 Participants
0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
PII (M9)
Post dose 2, Month 9
|
|---|---|---|---|---|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
ALT - PI(M1)
|
0 subjects
|
1 subjects
|
1 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
AST - PI(D5,12,14)
|
0 subjects
|
1 subjects
|
0 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
AST - PII(D2,5,8,12)
|
1 subjects
|
0 subjects
|
0 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
AST - PII(M7)
|
1 subjects
|
0 subjects
|
0 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
Neutro-Phil Count - PII(D5,8,12,14)
|
0 subjects
|
1 subjects
|
1 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
Platelets - PI(M1)
|
0 subjects
|
1 subjects
|
2 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
ALT - PI(D2,5,8,12)
|
0 subjects
|
1 subjects
|
1 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
ALT - PI(D5,12,14)
|
0 subjects
|
1 subjects
|
1 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
AST - PI(D2,5,8,12)
|
0 subjects
|
1 subjects
|
0 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
AST - PI(M1)
|
0 subjects
|
1 subjects
|
0 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
AST - PI(M6)
|
1 subjects
|
0 subjects
|
0 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
AST - PII(D5,8,12,14)
|
1 subjects
|
0 subjects
|
0 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
Haemato-Crit - Any point
|
0 subjects
|
0 subjects
|
0 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
Neutro-Phil Count - PI(D2,5,8,12)
|
0 subjects
|
0 subjects
|
1 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
Neutro-Phil Count - PI(D5,12,14)
|
0 subjects
|
0 subjects
|
1 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
Neutro-Phil Count - PI(M1)
|
0 subjects
|
0 subjects
|
1 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
Neutro-Phil Count - PI(M6)
|
0 subjects
|
1 subjects
|
1 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
Neutro-Phil Count - PII(D2,5,8,12)
|
0 subjects
|
1 subjects
|
1 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
Neutro-Phil Count - PII(M7)
|
0 subjects
|
1 subjects
|
1 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
Platelets - PI(D2,5,8,12)
|
0 subjects
|
1 subjects
|
2 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
Platelets - PI(D5,12,14)
|
0 subjects
|
1 subjects
|
2 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
Platelets - PI(M6)
|
0 subjects
|
0 subjects
|
2 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
Platelets - PII(D2,5,8,12)
|
0 subjects
|
0 subjects
|
2 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
Platelets - PII(D5,8,12,14)
|
0 subjects
|
0 subjects
|
2 subjects
|
—
|
|
Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose
Platelets - PII(M7)
|
0 subjects
|
0 subjects
|
2 subjects
|
—
|
SECONDARY outcome
Timeframe: 31 days post-vaccination per doseIncidence of abnormal dengue examination findings reported during the 31-Day (Days 0-30) post-vaccination period, per dose
Outcome measures
| Measure |
T-DEN F17
n=40 Participants
Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
T-DEN F19
n=40 Participants
Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
Placebo Comparator
n=40 Participants
0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
PII (M9)
Post dose 2, Month 9
|
|---|---|---|---|---|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 1 - Conunctival hemorrhage
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 1 - Hepatomegaly
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 1 - Lymphadenopathy
|
20.0 % of subjects
Interval 9.1 to 35.6
|
25.0 % of subjects
Interval 12.7 to 41.2
|
25.0 % of subjects
Interval 12.7 to 41.2
|
—
|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 1 - Splenomegaly
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 2 - Conjunctival hemorrhage
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 9.3
|
0.0 % of subjects
Interval 0.0 to 9.0
|
—
|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 2 - Mucosal hemorrhage
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 9.3
|
0.0 % of subjects
Interval 0.0 to 9.0
|
—
|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 2 - Rash
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 9.3
|
5.1 % of subjects
Interval 0.6 to 17.3
|
—
|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 2 - Splenomegaly
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 9.3
|
0.0 % of subjects
Interval 0.0 to 9.0
|
—
|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 1 - Conjunctival injection
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 1 - Generalized lymphadenopathy
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 1 - Generalized rash
|
5.0 % of subjects
Interval 0.06 to 16.9
|
5.0 % of subjects
Interval 0.06 to 16.9
|
0.0 % of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 1 - Mucosal hemorrhage
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 1 - Rash
|
5.0 % of subjects
Interval 0.6 to 16.9
|
5.0 % of subjects
Interval 0.6 to 16.9
|
0.0 % of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 1 - Skin hemorrhage
|
2.5 % of subjects
Interval 0.1 to 13.2
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 8.8
|
—
|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 2 - Conjunctival injection
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 9.3
|
0.0 % of subjects
Interval 0.0 to 9.0
|
—
|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 2 - Generalized lymphadenopathy
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 9.3
|
0.0 % of subjects
Interval 0.0 to 9.0
|
—
|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 2 - Generalized rash
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 9.3
|
0.0 % of subjects
Interval 0.0 to 9.0
|
—
|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 2 - Hepatomegaly
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 9.3
|
0.0 % of subjects
Interval 0.0 to 9.0
|
—
|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 2 - Lymphadenopathy
|
7.5 % of subjects
Interval 1.6 to 20.4
|
5.3 % of subjects
Interval 0.6 to 17.7
|
5.1 % of subjects
Interval 0.6 to 17.3
|
—
|
|
Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose
Dose 2 - Skin hemorrhage
|
0.0 % of subjects
Interval 0.0 to 8.8
|
0.0 % of subjects
Interval 0.0 to 9.3
|
0.0 % of subjects
Interval 0.0 to 9.0
|
—
|
SECONDARY outcome
Timeframe: 9 monthsNumber of subjects with incidence of suspected and confirmed dengue throughout the entire study period.
Outcome measures
| Measure |
T-DEN F17
n=40 Participants
Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
T-DEN F19
n=40 Participants
Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
Placebo Comparator
n=40 Participants
0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
PII (M9)
Post dose 2, Month 9
|
|---|---|---|---|---|
|
Incidence of Suspected and Confirmed Dengue Throughout the Entire Study Period.
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: post dose 1 and 2Percentage of subject with Tetravalent responses for neutralizing antibodies, according to pre-vaccination dengue immune status. There was no placebo run for DEN Monovalent. PRE = Pre-vaccination PI(M1) = Post Dose 1, Month 1 PII(M7) = Post Dose 2, Month 7
Outcome measures
| Measure |
T-DEN F17
n=40 Participants
Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
T-DEN F19
n=40 Participants
Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
Placebo Comparator
n=40 Participants
0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
PII (M9)
Post dose 2, Month 9
|
|---|---|---|---|---|
|
Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines
DEN Unprimed - PI(M1)
|
20.00 % of subjects
Interval 0.51 to 71.64
|
100 % of subjects
Interval 29.24 to 100.0
|
0.00 % of subjects
Interval 0.0 to 52.18
|
—
|
|
Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines
DEN Unprimed - PRE
|
0.00 % of subjects
Interval 0.0 to 52.18
|
0.00 % of subjects
Interval 0.0 to 60.24
|
0.00 % of subjects
Interval 0.0 to 52.18
|
—
|
|
Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines
DEN Unprimed - PII(M7)
|
100 % of subjects
Interval 47.82 to 100.0
|
100 % of subjects
Interval 29.24 to 100.0
|
0.00 % of subjects
Interval 0.0 to 52.18
|
—
|
|
Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines
DEN Monovalent - PRE
|
0.00 % of subjects
Interval 0.0 to 60.24
|
0.00 % of subjects
Interval 0.0 to 84.19
|
0.00 % of subjects
Interval 0.0 to 0.0
|
—
|
|
Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines
DEN Monovalent - PI(M1)
|
75.00 % of subjects
Interval 19.41 to 99.37
|
100 % of subjects
Interval 15.81 to 100.0
|
0.00 % of subjects
Interval 0.0 to 0.0
|
—
|
|
Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines
DEN Monovalent - PII(M7)
|
75.00 % of subjects
Interval 19.41 to 99.37
|
100 % of subjects
Interval 15.81 to 100.0
|
0.00 % of subjects
Interval 0.0 to 0.0
|
—
|
|
Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines
DEN Multivalent - PRE
|
86.67 % of subjects
Interval 69.28 to 96.24
|
90.91 % of subjects
Interval 75.67 to 98.08
|
97.14 % of subjects
Interval 85.08 to 99.93
|
—
|
|
Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines
DEN Multivalent - PI(M1)
|
100 % of subjects
Interval 88.43 to 100.0
|
100 % of subjects
Interval 89.42 to 100.0
|
97.14 % of subjects
Interval 85.08 to 99.93
|
—
|
|
Percentage of Subjects With Neutralizing Antibodies to Each DEN Type, After Each Dose of Study Vaccines
DEN Multivalent - PII(M7)
|
100 % of subjects
Interval 88.43 to 100.0
|
100 % of subjects
Interval 88.78 to 100.0
|
100 % of subjects
Interval 89.72 to 100.0
|
—
|
SECONDARY outcome
Timeframe: 9 monthsSeropositivity rates for neut. antibodies according to pre-vaccination flavivirus immune status-primed/unprimed subjects. PRE = Pre-vaccination PI(M1) = Post Dose 1, Month 1 PII(M7) = Post Dose 2, Month 7 PII(M9) = Post Dose 2, Month 9
Outcome measures
| Measure |
T-DEN F17
n=40 Participants
Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
T-DEN F19
n=40 Participants
Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
Placebo Comparator
n=40 Participants
0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
PII (M9)
Post dose 2, Month 9
|
|---|---|---|---|---|
|
Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines
DEN-1, >10 ED50 - PII(M9)
|
94.9 % of subjects
Interval 82.7 to 99.4
|
100 % of subjects
Interval 90.3 to 100.0
|
89.7 % of subjects
Interval 75.8 to 97.1
|
—
|
|
Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines
DEN-2, >10 ED50 - PRE
|
76.9 % of subjects
Interval 60.7 to 88.9
|
82.1 % of subjects
Interval 66.5 to 92.5
|
87.5 % of subjects
Interval 73.2 to 95.8
|
—
|
|
Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines
DEN-2, >10 ED50 - PI(M1)
|
92.3 % of subjects
Interval 79.1 to 98.4
|
100 % of subjects
Interval 90.7 to 100.0
|
87.5 % of subjects
Interval 73.2 to 95.8
|
—
|
|
Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines
DEN-2, >10 ED50 - PII(M7)
|
100 % of subjects
Interval 91.0 to 100.0
|
100 % of subjects
Interval 90.3 to 100.0
|
87.2 % of subjects
Interval 72.6 to 95.7
|
—
|
|
Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines
DEN-3, >10 ED50 - PI(M1)
|
87.2 % of subjects
Interval 72.6 to 95.7
|
100 % of subjects
Interval 90.7 to 100.0
|
87.5 % of subjects
Interval 73.2 to 95.8
|
—
|
|
Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines
DEN-3, >10 ED50 - PII(M9)
|
94.9 % of subjects
Interval 82.7 to 99.4
|
97.2 % of subjects
Interval 85.5 to 99.9
|
89.7 % of subjects
Interval 75.8 to 97.1
|
—
|
|
Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines
DEN-1, >10 ED50 - PRE
|
76.9 % of subjects
Interval 60.7 to 88.9
|
87.2 % of subjects
Interval 72.6 to 95.7
|
87.5 % of subjects
Interval 73.2 to 95.8
|
—
|
|
Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines
DEN-1, >10 ED50 - PI(M1)
|
89.7 % of subjects
Interval 75.8 to 97.1
|
100 % of subjects
Interval 90.7 to 100.0
|
87.5 % of subjects
Interval 73.2 to 95.8
|
—
|
|
Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines
DEN-1, >10 ED50 - PII(M7)
|
100 % of subjects
Interval 91.0 to 100.0
|
100 % of subjects
Interval 90.3 to 100.0
|
87.2 % of subjects
Interval 72.6 to 95.7
|
—
|
|
Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines
DEN-2, >10 ED50 - PII(M9)
|
100 % of subjects
Interval 91.0 to 100.0
|
100 % of subjects
Interval 90.3 to 100.0
|
89.7 % of subjects
Interval 75.8 to 97.1
|
—
|
|
Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines
DEN-3, >10 ED50 - PRE
|
71.8 % of subjects
Interval 55.1 to 85.0
|
82.1 % of subjects
Interval 66.5 to 92.5
|
85.0 % of subjects
Interval 70.2 to 94.3
|
—
|
|
Neutralizing Antibody Sero-response to Each DEN Type (Increase Neut.) Antibody From pre-to Post-vaccination, to be Determined by a Qualified Assay) After Each Dose of Study Vaccines
DEN-3, >10 ED50 - PII(M7)
|
97.4 % of subjects
Interval 86.5 to 99.9
|
100 % of subjects
Interval 90.3 to 100.0
|
87.2 % of subjects
Interval 72.6 to 95.7
|
—
|
SECONDARY outcome
Timeframe: within 7 monthsPercentage of subjects with incidence of measurable dengue viremia at specified time points after each dose. Negative = GEQ/uL results is equal to zero Undetermined = GEQ/uL result is below LOD Positive = GEQ/uL result is \>=LOD Missing = No data PI(M1) = Post Dose 1, Month 1 PII(D2,5,8,12) = Post Dose 2, Days 2, 5,8 and 12 PII(D5,8,12,14) = Post Dose 2, Days 5, 8, 12 and 14 PII(M7) = Post Dose 2, Month 7
Outcome measures
| Measure |
T-DEN F17
n=39 Participants
Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
T-DEN F19
n=40 Participants
Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
Placebo Comparator
n=40 Participants
0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
PII (M9)
Post dose 2, Month 9
|
|---|---|---|---|---|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PI(D5,12,14): Undetermined
|
0.0 % of subjects
|
2.6 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PI(D2,5,8,12): Undetermined
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PI(M1): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PII(M7): Undetermined
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PI(D5,12,14): Positive
|
2.6 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PI(D5,12,14): Negative
|
97.4 % of subjects
|
97.4 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PI(M1): Positive
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PI(M1): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PII(D2,5,8,12): Positive
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PII(D2,5,8,12): Negative
|
97.4 % of subjects
|
100 % of subjects
|
97.4 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PII(D5,8,12,14): Negative
|
94.7 % of subjects
|
100 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PII(D5,8,12,14): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PII(M7): Positive
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PII(M7): Undetermined
|
2.6 % of subjects
|
0.0 % of subjects
|
2.6 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PI(D2,5,8,12): Negative
|
100 % of subjects
|
97.4 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PI(D2,5,8,12): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PII(D2,5,8,12): Negative
|
100 % of subjects
|
100 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PII(D5,8,12,14): Negative
|
100 % of subjects
|
100 % of subjects
|
97.4 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PII(M7): Positive
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PII(M7): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PI(D2,5,8,12): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PI(D5,12,14): Undetermined
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PI(M1): Negative
|
100 % of subjects
|
100 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PI(M1): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PII(D5,8,12,14): Negative
|
100 % of subjects
|
100 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PII(D5,8,12,14): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PI(D2,5,8,12): Positive
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PI(D2,5,8,12): Negative
|
100 % of subjects
|
100 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PI(D2,5,8,12): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PI(D5,12,14): Positive
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PI(D5,12,14): Undetermined
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PI(D5,12,14): Negative
|
100 % of subjects
|
100 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PI(D5,12,14): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PI(M1): Positive
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PI(M1): Undetermined
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PI(M1): Negative
|
100 % of subjects
|
100 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PII(D2,5,8,12): Positive
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PII(D2,5,8,12): Undetermined
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PII(D2,5,8,12): Negative
|
100 % of subjects
|
100 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PII(D2,5,8,12): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PII(D5,8,12, 14): Positive
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PII(D5,8,12, 14): Undetermined
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PII(D5,8,12, 14): Negative
|
100 % of subjects
|
100 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PII(D5,8,12, 14): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PII(M7): Positive
|
0.0 % of subjects
|
0.0 % of subjects
|
2.6 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PII(M7): Negative
|
100 % of subjects
|
100 % of subjects
|
97.4 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-1, RNA - PII(M7): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PI(D2,5,8,12): Positive
|
0.0 % of subjects
|
2.6 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PI(D2,5,8,12): Undetermined
|
2.6 % of subjects
|
5.1 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PI(D2,5,8,12): Negative
|
97.4 % of subjects
|
92.3 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PI(D2,5,8,12): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PI(D5,12,14): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PI(M1): Undetermined
|
7.7 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PI(M1): Negative
|
92.3 % of subjects
|
100 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PII(D2,5,8,12): Undetermined
|
2.6 % of subjects
|
0.0 % of subjects
|
2.6 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PII(D2,5,8,12): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PII(D5,8,12,14): Positive
|
2.6 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PII(D5,8,12,14): Undetermined
|
2.6 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PII(M7): Negative
|
97.4 % of subjects
|
100 % of subjects
|
97.4 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-2, RNA - PII(M7): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PI(D2,5,8,12): Positive
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PI(D2,5,8,12): Undetermined
|
0.0 % of subjects
|
2.6 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PI(D5,12,14): Positive
|
0.0 % of subjects
|
2.6 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PI(D5,12,14): Undetermined
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PI(D5,12,14): Negative
|
100 % of subjects
|
97.4 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PI(D5,12,14): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PI(M1): Positive
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PI(M1): Undetermined
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PI(M1): Negative
|
100 % of subjects
|
100 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PI(M1): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PII(D2,5,8,12): Positive
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PII(D2,5,8,12): Undetermined
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PII(D2,5,8,12): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PII(D5,8,12,14): Positive
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PII(D5,8,12,14): Undetermined
|
0.0 % of subjects
|
0.0 % of subjects
|
2.6 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PII(D5,8,12,14): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PII(M7): Undetermined
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-3, RNA - PII(M7): Negative
|
100 % of subjects
|
100 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PI(D2,5,8,12): Positive
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PI(D2,5,8,12): Undetermined
|
2.6 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PI(D2,5,8,12): Negative
|
97.4 % of subjects
|
100 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PI(D5,12,14): Positive
|
2.6 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PI(D5,12,14): Negative
|
97.4 % of subjects
|
100 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PI(D5,12,14): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PI(M1): Positive
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PI(M1): Undetermined
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PII(D2,5,8,12): Positive
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PII(D2,5,8,12): Undetermined
|
0.0 % of subjects
|
2.9 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PII(D2,5,8,12): Negative
|
100 % of subjects
|
97.1 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PII(D2,5,8,12): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PII(D5,8,12,14): Positive
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PII(D5,8,12,14): Undetermined
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PII(M7): Positive
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PII(M7): Undetermined
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PII(M7): Negative
|
100 % of subjects
|
100 % of subjects
|
100 % of subjects
|
—
|
|
Incidence of Measurable Dengue Viremia at Specified Time Points After Each Dose
DEN-4, RNA - PII(M7): Missing
|
0.0 % of subjects
|
0.0 % of subjects
|
0.0 % of subjects
|
—
|
Adverse Events
T-DEN F17
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
T-DEN F19
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo Comparator
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
T-DEN F17
n=40 participants at risk
Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
T-DEN F19
n=40 participants at risk
Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
Placebo Comparator
n=40 participants at risk
0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Eptopic pregnancy
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
|
Gastrointestinal disorders
Abdominal wall hernia
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
|
Infections and infestations
Acute appendicitis
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
Other adverse events
| Measure |
T-DEN F17
n=40 participants at risk
Full Dose (0.5 mL) 0 and 6 months
T-DEN F17: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
T-DEN F19
n=40 participants at risk
Full Dose (0.5 mL) at 0 and 6 months
T-DEN F-19: A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
Placebo Comparator
n=40 participants at risk
0.5 mL sterile buffer at 0 and 6, subcutaneous injection
Placebo Comparator: A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.
|
|---|---|---|---|
|
General disorders
Pain
|
47.5%
19/40 • Number of events 19 • 9 months
|
25.0%
10/40 • Number of events 10 • 9 months
|
25.0%
10/40 • Number of events 10 • 9 months
|
|
Skin and subcutaneous tissue disorders
Redness
|
40.0%
16/40 • Number of events 16 • 9 months
|
37.5%
15/40 • Number of events 15 • 9 months
|
22.5%
9/40 • Number of events 9 • 9 months
|
|
General disorders
Swelling
|
22.5%
9/40 • Number of events 9 • 9 months
|
15.0%
6/40 • Number of events 6 • 9 months
|
12.5%
5/40 • Number of events 5 • 9 months
|
|
Gastrointestinal disorders
Abdonimal pain
|
7.5%
3/40 • Number of events 3 • 9 months
|
7.5%
3/40 • Number of events 3 • 9 months
|
7.5%
3/40 • Number of events 3 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
2/40 • Number of events 2 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
|
General disorders
Fatigue
|
40.0%
16/40 • Number of events 16 • 9 months
|
15.0%
6/40 • Number of events 6 • 9 months
|
17.5%
7/40 • Number of events 7 • 9 months
|
|
General disorders
Fever
|
22.5%
9/40 • Number of events 9 • 9 months
|
22.5%
9/40 • Number of events 9 • 9 months
|
15.0%
6/40 • Number of events 6 • 9 months
|
|
Nervous system disorders
Headache
|
45.0%
18/40 • Number of events 18 • 9 months
|
10.0%
4/40 • Number of events 4 • 9 months
|
20.0%
8/40 • Number of events 8 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Muscle aches
|
30.0%
12/40 • Number of events 12 • 9 months
|
5.0%
2/40 • Number of events 2 • 9 months
|
10.0%
4/40 • Number of events 4 • 9 months
|
|
Gastrointestinal disorders
Nausea
|
5.0%
2/40 • Number of events 2 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Eye disorders
Pain behind eyes
|
20.0%
8/40 • Number of events 8 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
7.5%
3/40 • Number of events 3 • 9 months
|
|
Eye disorders
Photophobia
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
5.0%
2/40 • Number of events 2 • 9 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
5/40 • Number of events 5 • 9 months
|
5.0%
2/40 • Number of events 2 • 9 months
|
10.0%
4/40 • Number of events 4 • 9 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Vomitng
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
|
Ear and labyrinth disorders
Ear pain
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
|
Ear and labyrinth disorders
Tinnitus
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
|
Eye disorders
Conjunctivitis
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
|
Eye disorders
Eye pain
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
|
Eye disorders
Eye pruritus
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
10.0%
4/40 • Number of events 4 • 9 months
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Consitpation
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
2/40 • Number of events 2 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Toothache
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
|
General disorders
Injection site pain
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
|
General disorders
Oedema peripheral
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
General disorders
Vessel puncture site pain
|
7.5%
3/40 • Number of events 3 • 9 months
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
|
Infections and infestations
Appendicitis
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
|
Infections and infestations
Folliculitis
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Infections and infestations
Laryngitis
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
|
Infections and infestations
Nasopharyngitis
|
15.0%
6/40 • Number of events 6 • 9 months
|
10.0%
4/40 • Number of events 4 • 9 months
|
5.0%
2/40 • Number of events 2 • 9 months
|
|
Infections and infestations
Pharyngitis
|
10.0%
4/40 • Number of events 4 • 9 months
|
10.0%
4/40 • Number of events 4 • 9 months
|
7.5%
3/40 • Number of events 3 • 9 months
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
5/40 • Number of events 5 • 9 months
|
0.00%
0/40 • 9 months
|
10.0%
4/40 • Number of events 4 • 9 months
|
|
Infections and infestations
Viral infection
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
|
Injury, poisoning and procedural complications
Animal bite
|
2.5%
1/40 • Number of events 1 • 9 months
|
5.0%
2/40 • Number of events 2 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/40 • 9 months
|
5.0%
2/40 • Number of events 2 • 9 months
|
0.00%
0/40 • 9 months
|
|
Nervous system disorders
Dizziness postural
|
2.5%
1/40 • Number of events 1 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
17.5%
7/40 • Number of events 7 • 9 months
|
7.5%
3/40 • Number of events 3 • 9 months
|
5.0%
2/40 • Number of events 2 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/40 • 9 months
|
5.0%
2/40 • Number of events 2 • 9 months
|
0.00%
0/40 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
2/40 • Number of events 2 • 9 months
|
7.5%
3/40 • Number of events 3 • 9 months
|
5.0%
2/40 • Number of events 2 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
7.5%
3/40 • Number of events 3 • 9 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.5%
1/40 • Number of events 1 • 9 months
|
5.0%
2/40 • Number of events 2 • 9 months
|
0.00%
0/40 • 9 months
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/40 • 9 months
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
Surgical and medical procedures
Venipuncture
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
0.00%
0/40 • 9 months
|
Additional Information
Verrachai Watanaveeradej, MD
Phramongkutklao Hospital, Bangkok, Thailand
Phone: 662-644-8971
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place