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Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Participants

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ClinicalTrials.gov Identifier: NCT02302066
Recruitment Status : Completed
First Posted : November 26, 2014
Results First Posted : February 24, 2020
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Dengue Fever
Interventions Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV)
Biological: TDV Placebo
Enrollment 1800
Recruitment Details Participants took part in the study at 3 investigative sites in Dominican Republic, Panama and Philippines from 05 Dec 2014 to 18 Feb 2019.
Pre-assignment Details Healthy volunteers were enrolled in a 1:2:5:1 ratio into 4 study groups: Group 1 received two doses of Tetravalent Dengue Vaccine (TDV), Group 2 received one dose of TDV, Group 3 received one dose of TDV along with booster vaccination and Group 4 received placebo.
Arm/Group Title Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control)
Hide Arm/Group Description Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365. Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365. Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91. Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
Period Title: Overall Study
Started 201 398 1002 199
Safety Analysis Set 200 398 998 198
Immunogenicity Subset 92 187 192 94
Per-Protocol Set (PPS) 83 171 174 81
Completed 168 323 830 158
Not Completed 33 75 172 41
Reason Not Completed
Adverse Event             1             1             3             0
Lost to Follow-up             4             5             24             7
Withdrawal by Subject             25             58             124             33
Pregnancy             2             10             12             0
Reason Not Specified             1             1             9             1
Arm/Group Title Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control) Total
Hide Arm/Group Description Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365. Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365. Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91. Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365. Total of all reporting groups
Overall Number of Baseline Participants 200 398 998 198 1794
Hide Baseline Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of trial vaccine.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 200 participants 398 participants 998 participants 198 participants 1794 participants
7.3  (4.01) 7.3  (4.14) 7.3  (4.06) 7.0  (3.96) 7.3  (4.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 398 participants 998 participants 198 participants 1794 participants
Female
100
  50.0%
207
  52.0%
486
  48.7%
95
  48.0%
888
  49.5%
Male
100
  50.0%
191
  48.0%
512
  51.3%
103
  52.0%
906
  50.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 398 participants 998 participants 198 participants 1794 participants
Hispanic or Latino
165
  82.5%
317
  79.6%
825
  82.7%
158
  79.8%
1465
  81.7%
Not Hispanic or Latino
35
  17.5%
81
  20.4%
173
  17.3%
40
  20.2%
329
  18.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 398 participants 998 participants 198 participants 1794 participants
American Indian or Alaska Native
102
  51.0%
204
  51.3%
505
  50.6%
101
  51.0%
912
  50.8%
Asian
35
  17.5%
82
  20.6%
174
  17.4%
40
  20.2%
331
  18.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
63
  31.5%
110
  27.6%
311
  31.2%
56
  28.3%
540
  30.1%
White
0
   0.0%
2
   0.5%
8
   0.8%
1
   0.5%
11
   0.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 200 participants 398 participants 998 participants 198 participants 1794 participants
122.1  (22.59) 120.9  (23.15) 121.4  (22.60) 119.3  (21.88) 121.2  (22.64)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 200 participants 398 participants 998 participants 198 participants 1794 participants
27.86  (15.069) 27.25  (14.368) 27.12  (13.612) 25.66  (13.371) 27.07  (13.924)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 200 participants 398 participants 998 participants 198 participants 1794 participants
17.42  (3.558) 17.43  (3.306) 17.29  (3.123) 16.93  (2.975) 17.30  (3.200)
[1]
Measure Description: Body Mass Index=weight/[height^2]
1.Primary Outcome
Title Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset
Hide Description GMTs of neutralizing antibodies were measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Data reported for up to Month 48 was collected at Months 1, 3, 6, 12, 13, 18, 24, 36 and 48.
Time Frame Up to Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set (PPS): All participants who received at least 1 dose of trial vaccine, who had a valid pre-dose and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. PPS included only participants from Immunogenicity Subset. Number analyzed are participants with data available at the given timepoint.
Arm/Group Title Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control)
Hide Arm/Group Description:
Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.
Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.
Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.
Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
Overall Number of Participants Analyzed 83 171 174 81
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
DENV-1, Day 28 (Month 1) Number Analyzed 83 participants 171 participants 174 participants 81 participants
768.2
(498.7 to 1183.4)
999.7
(723.6 to 1381.2)
920.9
(689.4 to 1230.1)
60.7
(31.8 to 116.0)
DENV-2, Day 28 (Month 1) Number Analyzed 83 participants 171 participants 174 participants 81 participants
4329.7
(2847.6 to 6583.2)
4219.3
(3118.9 to 5708.1)
3572.2
(2674.6 to 4771.2)
75.0
(39.6 to 141.8)
DENV-3, Day 28 (Month 1) Number Analyzed 83 participants 171 participants 174 participants 81 participants
216.1
(124.7 to 374.6)
352.8
(237.5 to 524.2)
363.6
(249.8 to 529.1)
45.8
(25.9 to 81.1)
DENV-4, Day 28 (Month 1) Number Analyzed 83 participants 171 participants 174 participants 81 participants
199.2
(130.0 to 305.2)
317.3
(232.2 to 433.5)
260.4
(195.0 to 347.7)
24.8
(16.2 to 38.0)
DENV-1, Day 91 (Month 3) Number Analyzed 83 participants 171 participants 174 participants 81 participants
422.3
(256.7 to 695.0)
684.2
(491.4 to 952.8)
708.9
(522.6 to 961.6)
64.6
(33.8 to 123.4)
DENV-2, Day 91 (Month 3) Number Analyzed 83 participants 171 participants 174 participants 81 participants
1810.1
(1311.1 to 2499.2)
2216.9
(1750.8 to 2807.2)
1709.6
(1370.4 to 2132.7)
76.0
(40.1 to 144.3)
DENV-3, Day 91 (Month 3) Number Analyzed 83 participants 171 participants 174 participants 81 participants
140.8
(83.8 to 236.6)
250.8
(174.5 to 360.6)
251.9
(175.7 to 361.2)
39.3
(22.6 to 68.2)
DENV-4, Day 91 (Month 3) Number Analyzed 83 participants 171 participants 174 participants 81 participants
122.9
(77.6 to 194.6)
170.8
(122.6 to 237.8)
147.0
(108.4 to 199.2)
23.4
(14.9 to 36.9)
DENV-1, Day 180 (Month 6) Number Analyzed 83 participants 170 participants 174 participants 81 participants
448.8
(293.0 to 687.5)
463.7
(329.5 to 652.6)
538.9
(391.2 to 742.3)
55.7
(29.2 to 106.6)
DENV-2, Day 180 (Month 6) Number Analyzed 83 participants 170 participants 174 participants 81 participants
1461.5
(1071.7 to 1992.9)
1682.9
(1333.5 to 2124.0)
1335.1
(1067.7 to 1669.5)
77.2
(39.8 to 149.6)
DENV-3, Day 180 (Month 6) Number Analyzed 83 participants 170 participants 174 participants 81 participants
150.1
(96.9 to 232.6)
166.3
(117.6 to 235.3)
173.9
(125.8 to 240.5)
37.4
(21.7 to 64.6)
DENV-4, Day 180 (Month 6) Number Analyzed 83 participants 170 participants 174 participants 81 participants
109.1
(72.9 to 163.2)
110.0
(81.0 to 149.2)
92.3
(68.7 to 123.9)
22.3
(14.1 to 35.1)
DENV-1, Day 365 (Month 12) Number Analyzed 79 participants 161 participants 164 participants 76 participants
370.7
(232.3 to 591.8)
409.6
(287.9 to 582.5)
487.3
(346.2 to 686.0)
72.7
(38.0 to 139.1)
DENV-2, Day 365 (Month 12) Number Analyzed 79 participants 161 participants 164 participants 76 participants
1070.0
(746.7 to 1533.2)
1529.8
(1179.0 to 1985.0)
1041.0
(802.8 to 1349.9)
133.9
(67.7 to 264.9)
DENV-3, Day 365 (Month 12) Number Analyzed 79 participants 161 participants 164 participants 76 participants
166.8
(101.4 to 274.2)
201.0
(139.0 to 290.4)
199.2
(138.7 to 286.1)
62.0
(34.6 to 111.0)
DENV-4, Day 365 (Month 12) Number Analyzed 79 participants 161 participants 164 participants 76 participants
87.9
(57.7 to 133.8)
85.6
(63.0 to 116.3)
89.3
(64.5 to 123.6)
29.3
(18.5 to 46.6)
DENV-1, Day 393 (Month 13) Number Analyzed 80 participants 163 participants 167 participants 75 participants
454.4
(273.4 to 755.2)
385.8
(271.6 to 548.2)
1598.8
(1258.2 to 2031.6)
80.6
(41.4 to 156.9)
DENV-2, Day 393 (Month 13) Number Analyzed 80 participants 163 participants 167 participants 75 participants
1152.4
(796.3 to 1667.6)
1384.1
(1066.3 to 1796.7)
1866.1
(1551.4 to 2244.6)
129.5
(64.9 to 258.6)
DENV-3, Day 393 (Month 13) Number Analyzed 80 participants 163 participants 167 participants 75 participants
192.1
(115.3 to 320.3)
225.1
(157.1 to 322.7)
767.6
(615.4 to 957.4)
68.5
(36.5 to 128.8)
DENV-4, Day 393 (Month 13) Number Analyzed 80 participants 163 participants 167 participants 75 participants
90.5
(58.1 to 141.2)
86.3
(64.2 to 116.1)
278.0
(226.6 to 340.9)
28.8
(18.0 to 46.0)
DENV-1, Day 540 (Month 18) Number Analyzed 81 participants 168 participants 172 participants 80 participants
475.9
(286.3 to 791.0)
461.3
(329.1 to 646.6)
1056.3
(804.0 to 1387.9)
92.2
(49.1 to 172.9)
DENV-2, Day 540 (Month 18) Number Analyzed 81 participants 168 participants 172 participants 80 participants
1211.5
(841.6 to 1744.1)
1241.8
(947.1 to 1628.1)
1456.6
(1181.7 to 1795.5)
176.7
(92.8 to 336.7)
DENV-3, Day 540 (Month 18) Number Analyzed 81 participants 168 participants 172 participants 80 participants
285.5
(170.7 to 477.5)
298.0
(205.0 to 433.3)
548.0
(411.2 to 730.3)
77.6
(44.0 to 136.9)
DENV-4, Day 540 (Month 18) Number Analyzed 81 participants 168 participants 172 participants 80 participants
98.3
(64.5 to 149.9)
102.0
(75.1 to 138.6)
171.6
(132.9 to 221.6)
33.1
(21.1 to 51.9)
DENV-1, Day 730 (Month 24) Number Analyzed 71 participants 145 participants 148 participants 70 participants
471.1
(289.9 to 765.4)
441.5
(302.4 to 644.3)
920.9
(699.9 to 1211.8)
114.5
(58.8 to 223.0)
DENV-2, Day 730 (Month 24) Number Analyzed 71 participants 145 participants 148 participants 70 participants
1395.5
(962.1 to 2024.3)
1748.2
(1328.8 to 2300.0)
1685.8
(1346.1 to 2111.3)
244.6
(118.2 to 506.3)
DENV-3, Day 730 (Month 24) Number Analyzed 71 participants 145 participants 148 participants 70 participants
243.0
(144.2 to 409.3)
276.0
(188.3 to 404.7)
470.1
(347.7 to 635.7)
90.8
(46.6 to 176.8)
DENV-4, Day 730 (Month 24) Number Analyzed 71 participants 145 participants 148 participants 70 participants
180.0
(113.5 to 285.6)
170.4
(121.3 to 239.4)
285.9
(219.6 to 372.1)
56.3
(32.1 to 98.9)
DENV-1, Day 1095 (Month 36) Number Analyzed 66 participants 137 participants 139 participants 66 participants
495.2
(278.9 to 879.3)
364.7
(246.3 to 540.1)
742.8
(553.6 to 996.8)
90.7
(47.3 to 173.7)
DENV-2, Day 1095 (Month 36) Number Analyzed 66 participants 137 participants 139 participants 66 participants
1394.2
(946.4 to 2053.9)
1408.4
(1057.3 to 1876.0)
1476.2
(1153.3 to 1889.7)
203.5
(100.0 to 414.0)
DENV-3, Day 1095 (Month 36) Number Analyzed 66 participants 137 participants 139 participants 66 participants
262.8
(158.2 to 436.5)
214.9
(144.5 to 319.7)
364.8
(266.4 to 499.4)
66.4
(35.1 to 125.5)
DENV-4, Day 1095 (Month 36) Number Analyzed 66 participants 137 participants 139 participants 66 participants
201.8
(125.2 to 325.3)
148.1
(104.8 to 209.3)
236.1
(179.4 to 310.6)
45.7
(27.0 to 77.2)
DENV-1, Day 1460 (Month 48) Number Analyzed 65 participants 133 participants 136 participants 63 participants
377.8
(226.1 to 631.5)
421.0
(285.1 to 621.9)
718.5
(537.7 to 959.9)
100.0
(49.8 to 200.7)
DENV-2, Day 1460 (Month 48) Number Analyzed 65 participants 133 participants 136 participants 63 participants
1051.9
(732.2 to 1511.1)
1319.0
(970.1 to 1793.5)
1200.0
(927.1 to 1553.1)
208.1
(99.2 to 436.5)
DENV-3, Day 1460 (Month 48) Number Analyzed 65 participants 133 participants 136 participants 63 participants
183.4
(112.9 to 298.0)
200.5
(135.1 to 297.6)
287.5
(210.7 to 392.4)
71.3
(36.6 to 138.9)
DENV-4, Day 1460 (Month 48) Number Analyzed 65 participants 133 participants 136 participants 63 participants
152.0
(96.6 to 239.2)
164.1
(114.1 to 236.0)
218.6
(164.7 to 290.2)
46.2
(26.1 to 81.8)
2.Secondary Outcome
Title Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset
Hide Description Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity defined as a reciprocal neutralizing titer ≥10 (for each serotype). The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Time Frame Months 1, 3, 6, 12, 13, 18, 24, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
PPS included all participants who received at least 1 dose of trial vaccine, who had a valid pre-dose and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. PPS included only participants from Immunogenicity Subset. Number analyzed are participants with data available at the given timepoint.
Arm/Group Title Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control)
Hide Arm/Group Description:
Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.
Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.
Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.
Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
Overall Number of Participants Analyzed 83 171 174 81
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
DENV-1, Day 28 (Month 1) Number Analyzed 83 participants 171 participants 174 participants 81 participants
97.6
(91.6 to 99.7)
97.7
(94.1 to 99.4)
100.0
(97.9 to 100.0)
49.4
(38.1 to 60.7)
DENV-2, Day 28 (Month 1) Number Analyzed 83 participants 171 participants 174 participants 81 participants
96.4
(89.8 to 99.2)
95.3
(91.0 to 98.0)
96.6
(92.6 to 98.7)
51.9
(40.5 to 63.1)
DENV-3, Day 28 (Month 1) Number Analyzed 83 participants 171 participants 174 participants 81 participants
88.0
(79.0 to 94.1)
90.1
(84.6 to 94.1)
90.8
(85.5 to 94.7)
50.6
(39.3 to 61.9)
DENV-4, Day 28 (Month 1) Number Analyzed 83 participants 171 participants 174 participants 81 participants
94.0
(86.5 to 98.0)
93.6
(88.8 to 96.7)
95.4
(91.1 to 98.0)
49.4
(38.1 to 60.7)
DENV-1, Day 91 (Month 3) Number Analyzed 83 participants 171 participants 174 participants 81 participants
95.2
(88.1 to 98.7)
97.7
(94.1 to 99.4)
99.4
(96.8 to 100.0)
51.9
(40.5 to 63.1)
DENV-2, Day 91 (Month 3) Number Analyzed 83 participants 171 participants 174 participants 81 participants
98.8
(93.5 to 100.0)
98.8
(95.8 to 99.9)
99.4
(96.8 to 100.0)
53.1
(41.7 to 64.3)
DENV-3, Day 91 (Month 3) Number Analyzed 83 participants 171 participants 174 participants 81 participants
89.2
(80.4 to 94.9)
95.3
(91.0 to 98.0)
91.4
(86.2 to 95.1)
48.1
(36.9 to 59.5)
DENV-4, Day 91 (Month 3) Number Analyzed 83 participants 171 participants 174 participants 81 participants
88.0
(79.0 to 94.1)
90.6
(85.3 to 94.6)
90.8
(85.5 to 94.7)
45.7
(34.6 to 57.1)
DENV-1, Day 180 (Month 6) Number Analyzed 83 participants 170 participants 174 participants 81 participants
100.0
(95.7 to 100.0)
97.1
(93.3 to 99.0)
99.4
(96.8 to 100.0)
49.4
(38.1 to 60.7)
DENV-2, Day 180 (Month 6) Number Analyzed 83 participants 170 participants 174 participants 81 participants
98.8
(93.5 to 100.0)
99.4
(96.8 to 100.0)
99.4
(96.8 to 100.0)
49.4
(38.1 to 60.7)
DENV-3, Day 180 (Month 6) Number Analyzed 83 participants 170 participants 174 participants 81 participants
98.8
(93.5 to 100.0)
92.9
(88.0 to 96.3)
93.1
(88.3 to 96.4)
48.1
(36.9 to 59.5)
DENV-4, Day 180 (Month 6) Number Analyzed 83 participants 170 participants 174 participants 81 participants
92.8
(84.9 to 97.3)
90.6
(85.2 to 94.5)
85.1
(78.9 to 90.0)
44.4
(33.4 to 55.9)
DENV-1, Day 365 (Month 12) Number Analyzed 79 participants 161 participants 164 participants 76 participants
98.7
(93.1 to 100.0)
97.5
(93.8 to 99.3)
97.6
(93.9 to 99.3)
57.9
(46.0 to 69.1)
DENV-2, Day 365 (Month 12) Number Analyzed 79 participants 161 participants 164 participants 76 participants
98.7
(93.1 to 100.0)
99.4
(96.6 to 100.0)
100.0
(97.8 to 100.0)
60.5
(48.6 to 71.6)
DENV-3, Day 365 (Month 12) Number Analyzed 79 participants 161 participants 164 participants 76 participants
94.9
(87.5 to 98.6)
94.4
(89.7 to 97.4)
90.2
(84.6 to 94.3)
57.9
(46.0 to 69.1)
DENV-4, Day 365 (Month 12) Number Analyzed 79 participants 161 participants 164 participants 76 participants
92.4
(84.2 to 97.2)
85.1
(78.6 to 90.2)
82.9
(76.3 to 88.3)
55.3
(43.4 to 66.7)
DENV-1, Day 393 (Month 13) Number Analyzed 80 participants 163 participants 167 participants 75 participants
97.5
(91.3 to 99.7)
95.7
(91.4 to 98.3)
100.0
(97.8 to 100.0)
60.0
(48.0 to 71.1)
DENV-2, Day 393 (Month 13) Number Analyzed 80 participants 163 participants 167 participants 75 participants
98.8
(93.2 to 100.0)
98.8
(95.6 to 99.9)
100.0
(97.8 to 100.0)
61.3
(49.4 to 72.4)
DENV-3, Day 393 (Month 13) Number Analyzed 80 participants 163 participants 167 participants 75 participants
95.0
(87.7 to 98.6)
95.1
(90.6 to 97.9)
100.0
(97.8 to 100.0)
57.3
(45.4 to 68.7)
DENV-4, Day 393 (Month 13) Number Analyzed 80 participants 163 participants 167 participants 75 participants
90.0
(81.2 to 95.6)
86.5
(80.3 to 91.3)
100.0
(97.8 to 100.0)
53.3
(41.4 to 64.9)
DENV-1, Day 540 (Month 18) Number Analyzed 81 participants 168 participants 172 participants 80 participants
95.1
(87.8 to 98.6)
97.0
(93.2 to 99.0)
98.8
(95.9 to 99.9)
62.5
(51.0 to 73.1)
DENV-2, Day 540 (Month 18) Number Analyzed 81 participants 168 participants 172 participants 80 participants
98.8
(93.3 to 100.0)
97.6
(94.0 to 99.3)
100.0
(97.9 to 100.0)
68.8
(57.4 to 78.7)
DENV-3, Day 540 (Month 18) Number Analyzed 81 participants 168 participants 172 participants 80 participants
95.1
(87.8 to 98.6)
92.3
(87.1 to 95.8)
98.3
(95.0 to 99.6)
63.8
(52.2 to 74.2)
DENV-4, Day 540 (Month 18) Number Analyzed 81 participants 168 participants 172 participants 80 participants
87.7
(78.5 to 93.9)
86.9
(80.8 to 91.6)
97.1
(93.3 to 99.0)
57.5
(45.9 to 68.5)
DENV-1, Day 730 (Month 24) Number Analyzed 71 participants 145 participants 148 participants 70 participants
100.0
(94.9 to 100.0)
95.9
(91.2 to 98.5)
100.0
(97.5 to 100.0)
68.6
(56.4 to 79.1)
DENV-2, Day 730 (Month 24) Number Analyzed 71 participants 145 participants 148 participants 70 participants
100.0
(94.9 to 100.0)
99.3
(96.2 to 100.0)
100.0
(97.5 to 100.0)
71.4
(59.4 to 81.6)
DENV-3, Day 730 (Month 24) Number Analyzed 71 participants 145 participants 148 participants 70 participants
94.4
(86.2 to 98.4)
93.1
(87.7 to 96.6)
98.6
(95.2 to 99.8)
65.7
(53.4 to 76.7)
DENV-4, Day 730 (Month 24) Number Analyzed 71 participants 145 participants 148 participants 70 participants
94.4
(86.2 to 98.4)
91.7
(86.0 to 95.7)
98.6
(95.2 to 99.8)
61.4
(49.0 to 72.8)
DENV-1, Day 1095 (Month 36) Number Analyzed 66 participants 137 participants 139 participants 66 participants
100.0
(94.6 to 100.0)
92.7
(87.0 to 96.4)
100.0
(97.4 to 100.0)
68.2
(55.6 to 79.1)
DENV-2, Day 1095 (Month 36) Number Analyzed 66 participants 137 participants 139 participants 66 participants
100.0
(94.6 to 100.0)
99.3
(96.0 to 100.0)
100.0
(97.4 to 100.0)
71.2
(58.7 to 81.7)
DENV-3, Day 1095 (Month 36) Number Analyzed 66 participants 137 participants 139 participants 66 participants
97.0
(89.5 to 99.6)
88.3
(81.7 to 93.2)
98.6
(94.9 to 99.8)
63.6
(50.9 to 75.1)
DENV-4, Day 1095 (Month 36) Number Analyzed 66 participants 137 participants 139 participants 66 participants
95.5
(87.3 to 99.1)
88.3
(81.7 to 93.2)
98.6
(94.9 to 99.8)
63.6
(50.9 to 75.1)
DENV-1, Day 1460 (Month 48) Number Analyzed 65 participants 133 participants 136 participants 63 participants
96.9
(89.3 to 99.6)
94.7
(89.5 to 97.9)
100.0
(97.3 to 100.0)
68.3
(55.3 to 79.4)
DENV-2, Day 1460 (Month 48) Number Analyzed 65 participants 133 participants 136 participants 63 participants
100.0
(94.5 to 100.0)
98.5
(94.7 to 99.8)
100.0
(97.3 to 100.0)
68.3
(55.3 to 79.4)
DENV-3, Day 1460 (Month 48) Number Analyzed 65 participants 133 participants 136 participants 63 participants
95.4
(87.1 to 99.0)
90.2
(83.9 to 94.7)
97.8
(93.7 to 99.5)
63.5
(50.4 to 75.3)
DENV-4, Day 1460 (Month 48) Number Analyzed 65 participants 133 participants 136 participants 63 participants
90.8
(81.0 to 96.5)
91.0
(84.8 to 95.3)
99.3
(96.0 to 100.0)
60.3
(47.2 to 72.4)
3.Secondary Outcome
Title Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination
Hide Description Solicited local injection included pain, erythema at injection site, and swelling at injection site. They were collected using a diary and graded as [Grade 0 (no pain), 1 (mild: minor reaction to touch), 2 (moderate: cries/protests on touch) and 3 (severe: cries when limb is moved/spontaneously painful)]. Erythema and Swelling at injection site were graded as Grade 0 (<10 mm), 1 (mild: ≥10 - ≤ 20 mm), 2 (moderate: > 20 - ≤ 40 mm) and 3 (severe: > 40 mm).
Time Frame Within 7 days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Only participants in immunogenicity subset were included. Data were summarized separately for each age group. Number analyzed are participants with data available for the category. Only categories for which there was at least 1 participant are reported.
Arm/Group Title Group 1 (TDV 2-Dose) Infant/Toddler Group 2 (TDV 1-Dose) Infant/Toddler Group 3 (TDV 2-Dose) Infant/Toddler Group 4 (Placebo Control) Infant/Toddler
Hide Arm/Group Description:
Participants aged <6 years received Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.
Participants aged <6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.
Participants aged <6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.
Participants aged <6 years received placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
Overall Number of Participants Analyzed 29 60 62 32
Measure Type: Number
Unit of Measure: percentage of participants
After Vaccination 1, Pain: Any Number Analyzed 27 participants 54 participants 55 participants 28 participants
11.1 5.6 12.7 7.1
After Vaccination 1, Pain: Mild Number Analyzed 27 participants 54 participants 55 participants 28 participants
11.1 1.9 10.9 3.6
After Vaccination 1, Pain: Moderate Number Analyzed 27 participants 54 participants 55 participants 28 participants
0 3.7 1.8 3.6
After Vaccination 1, Erythema: Any Number Analyzed 27 participants 53 participants 55 participants 27 participants
0 3.8 3.6 0
After Vaccination 1, Erythema (1-2 cm) Number Analyzed 27 participants 53 participants 55 participants 27 participants
0 3.8 3.6 0
After Vaccination 1, Swelling: Any Number Analyzed 27 participants 53 participants 55 participants 27 participants
0 3.8 0 0
After Vaccination 1, Swelling (1-2 cm) Number Analyzed 27 participants 53 participants 55 participants 27 participants
0 3.8 0 0
After Vaccination 2, Pain: Any Number Analyzed 26 participants 53 participants 54 participants 29 participants
3.8 3.8 13.0 6.9
After Vaccination 2, Pain: Mild Number Analyzed 26 participants 53 participants 54 participants 29 participants
3.8 3.8 9.3 6.9
After Vaccination 2, Pain: Moderate Number Analyzed 26 participants 53 participants 54 participants 29 participants
0 0 3.7 0
After Vaccination 3, Pain: Any Number Analyzed 27 participants 56 participants 60 participants 29 participants
7.4 8.9 15.0 3.4
After Vaccination 3, Pain: Mild Number Analyzed 27 participants 56 participants 60 participants 29 participants
7.4 7.1 11.7 3.4
After Vaccination 3, Pain: Moderate Number Analyzed 27 participants 56 participants 60 participants 29 participants
0 1.8 1.7 0
After Vaccination 3, Pain: Severe Number Analyzed 27 participants 56 participants 60 participants 29 participants
0 0 1.7 0
After Vaccination 3, Swelling: Any Number Analyzed 27 participants 56 participants 59 participants 29 participants
0 0 1.7 0
After Vaccination 3, Swelling (1-2 cm) Number Analyzed 27 participants 56 participants 59 participants 29 participants
0 0 1.7 0
4.Secondary Outcome
Title Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination
Hide Description Solicited local injection site reactions were collected by participant diary and graded as [Grade 0 (no pain), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents daily activity with or without treatment)]. Erythema and Swelling at injection site were graded as Grade 0 (<25 mm), 1 (mild: ≥25 - ≤ 50 mm), 2 (moderate: > 50 - ≤ 100 mm).
Time Frame Within 7 days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Only participants in immunogenicity subset were included. Data were summarized separately for each age group. Number analyzed are participants with data available for the category. Only categories for which there was at least 1 participant are reported.
Arm/Group Title Group 1 (TDV 2-Dose) Adult/Children Group 2 (TDV 1-Dose) Adult/Children Group 3 (TDV 1-Dose + Booster) Adult/Children Group 4 (Placebo Control) Adult/Children
Hide Arm/Group Description:
Participants aged ≥6 years received Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.
Participants aged ≥6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.
Participants aged ≥6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.
Participant aged ≥6 years received placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
Overall Number of Participants Analyzed 62 127 129 61
Measure Type: Number
Unit of Measure: percentage of participants
After Vaccination 1, Pain: Any Number Analyzed 60 participants 126 participants 123 participants 57 participants
25.0 31.7 26.8 8.8
After Vaccination 1, Pain: Mild Number Analyzed 60 participants 126 participants 123 participants 57 participants
23.3 28.6 22.0 7.0
After Vaccination 1, Pain: Moderate Number Analyzed 60 participants 126 participants 123 participants 57 participants
1.7 2.4 4.1 1.8
After Vaccination 1, Pain: Severe Number Analyzed 62 participants 126 participants 123 participants 57 participants
0 0.8 0.8 0
After Vaccination 1, Erythema: Any Number Analyzed 60 participants 126 participants 122 participants 57 participants
0 0.8 0 0
After Vaccination 1, Erythema (2.5-5 cm) Number Analyzed 60 participants 126 participants 122 participants 57 participants
0 0.8 0 0
After Vaccination 1, Swelling: Any Number Analyzed 60 participants 126 participants 122 participants 57 participants
0 0 0 1.8
After Vaccination 1, Swelling: (2.5-5 cm) Number Analyzed 60 participants 126 participants 122 participants 57 participants
0 0 0 1.8
After Vaccination 2, Pain: Any Number Analyzed 60 participants 116 participants 119 participants 55 participants
31.7 18.1 10.9 14.5
After Vaccination 2, Pain: Mild Number Analyzed 60 participants 116 participants 119 participants 55 participants
20.0 16.4 6.7 10.9
After Vaccination 2, Pain: Moderate Number Analyzed 60 participants 116 participants 119 participants 55 participants
5.0 0 4.2 1.8
After Vaccination 2, Pain: Severe Number Analyzed 60 participants 116 participants 119 participants 55 participants
6.7 1.7 0 1.8
After Vaccination 3, Pain: Any Number Analyzed 59 participants 115 participants 120 participants 55 participants
16.9 20.0 19.2 16.4
After Vaccination 3, Pain: Mild Number Analyzed 59 participants 115 participants 120 participants 55 participants
13.6 18.3 15.8 12.7
After Vaccination 3, Pain: Moderate Number Analyzed 59 participants 115 participants 120 participants 55 participants
3.4 0 3.3 3.6
After Vaccination 3, Pain: Severe Number Analyzed 59 participants 115 participants 120 participants 55 participants
0 1.7 0 0
After Vaccination 3, Erythema: Any Number Analyzed 58 participants 115 participants 120 participants 55 participants
0 0 0.8 0
After Vaccination 3, Erythema (2.5-5 cm) Number Analyzed 58 participants 115 participants 120 participants 55 participants
0 0 0.8 0
5.Secondary Outcome
Title Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination
Hide Description Solicited systemic AEs were collected within 14 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it.
Time Frame Within 14 days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Only participants in immunogenicity subset were included. Data were summarized separately for each age group. Number analyzed are participants with data available for the category. Only categories for which there was at least 1 participant are reported.
Arm/Group Title Group 1 (TDV 2-Dose) Infant/Toddler Group 2 (TDV 1-Dose) Infant/Toddler Group 3 (TDV 1-Dose + Booster) Infant/Toddler Group 4 (Placebo Control) Infant/Toddler
Hide Arm/Group Description:
Participants aged <6 years received Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.
Participants aged <6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.
Participants aged <6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.
Participants aged <6 years received placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
Overall Number of Participants Analyzed 29 60 62 32
Measure Type: Number
Unit of Measure: percentage of participants
After Vaccination 1, Irritability: Any Number Analyzed 27 participants 54 participants 55 participants 28 participants
3.7 1.9 9.1 0
After Vaccination 1, Irritability: Mild Number Analyzed 27 participants 54 participants 55 participants 28 participants
3.7 0 3.6 0
After Vaccination 1, Irritability: Moderate Number Analyzed 27 participants 54 participants 55 participants 27 participants
0 1.9 3.6 0
After Vaccination 1, Irritability: Severe Number Analyzed 27 participants 54 participants 55 participants 27 participants
0 0 1.8 0
After Vaccination 1,Drowsiness: Any Number Analyzed 27 participants 54 participants 55 participants 28 participants
0 7.4 7.3 7.1
After Vaccination 1, Drowsiness: Mild Number Analyzed 27 participants 54 participants 55 participants 28 participants
0 7.4 5.5 7.1
After Vaccination 1, Drowsiness: Moderate Number Analyzed 27 participants 54 participants 55 participants 28 participants
0 0 1.8 0
After Vaccination 1,Loss of Appetite:Any Number Analyzed 27 participants 54 participants 55 participants 28 participants
7.4 9.3 10.9 7.1
After Vaccination 1,Loss of Appetite: Mild Number Analyzed 27 participants 54 participants 55 participants 28 participants
7.4 7.4 5.5 0
After Vaccination 1, Loss of Appetite: Moderate Number Analyzed 27 participants 54 participants 55 participants 28 participants
0 1.9 3.6 7.1
After Vaccination 1, Loss of Appetite: Severe Number Analyzed 27 participants 54 participants 55 participants 28 participants
0 0 1.8 0
After Vaccination 1, Fever: Any Number Analyzed 25 participants 50 participants 52 participants 27 participants
0 6.0 5.8 3.7
After Vaccination 1, Fever (38.0 - < 38.5 °C) Number Analyzed 25 participants 50 participants 52 participants 27 participants
0 2.0 3.8 0
After Vaccination 1, Fever (38.5 - < 39.0 °C) Number Analyzed 25 participants 50 participants 52 participants 27 participants
0 4.0 1.9 3.7
After Vaccination 2, Irritability:Any Number Analyzed 26 participants 53 participants 53 participants 28 participants
15.4 1.9 1.9 10.7
After Vaccination 2, Irritability: Mild Number Analyzed 26 participants 53 participants 53 participants 28 participants
15.4 1.9 1.9 10.7
After Vaccination 2, Drowsiness: Any Number Analyzed 26 participants 53 participants 53 participants 28 participants
3.8 3.8 3.8 0
After Vaccination 2, Drowsiness:Mild Number Analyzed 26 participants 53 participants 53 participants 28 participants
3.8 3.8 3.8 0
After Vaccination 2, Loss of Appetite: Any Number Analyzed 26 participants 53 participants 53 participants 28 participants
7.7 13.2 5.7 0
After Vaccination 2, Loss of Appetite: Mild Number Analyzed 26 participants 53 participants 53 participants 28 participants
3.8 9.4 5.7 0
After Vaccination 2, Loss of Appetite: Moderate Number Analyzed 26 participants 53 participants 53 participants 28 participants
3.8 1.9 0 0
After Vaccination 2, Loss of Appetite: Severe Number Analyzed 26 participants 53 participants 53 participants 28 participants
0 1.9 0 0
After Vaccination 2, Fever, Any Number Analyzed 25 participants 52 participants 52 participants 28 participants
16.0 9.6 11.5 3.6
After Vaccination 2, Fever (38.0 - < 38.5 °C) Number Analyzed 25 participants 52 participants 52 participants 28 participants
0 3.8 5.8 0
After Vaccination 2, Fever (38.5 - < 39.0 °C) Number Analyzed 25 participants 52 participants 52 participants 28 participants
8.0 5.8 3.8 3.6
After Vaccination 2, Fever (39.0 - < 39.5 °C) Number Analyzed 25 participants 52 participants 52 participants 28 participants
4.0 0 1.9 0
After Vaccination 2, Fever (39.5 - < 40.0 °C) Number Analyzed 25 participants 52 participants 52 participants 28 participants
4.0 0 0 0
After Vaccination 3,Irritability: Any Number Analyzed 27 participants 56 participants 59 participants 29 participants
3.7 0 1.7 10.3
After Vaccination 3, Irritability: Mild Number Analyzed 27 participants 56 participants 59 participants 29 participants
3.7 0 0 6.9
After Vaccination 3, Irritability: Moderate Number Analyzed 27 participants 56 participants 59 participants 29 participants
0 0 1.7 3.4
After Vaccination 3,Drowsiness: Any Number Analyzed 27 participants 56 participants 59 participants 29 participants
3.7 3.6 3.4 3.4
After Vaccination 1,Drowsiness: Mild Number Analyzed 27 participants 56 participants 59 participants 29 participants
3.7 3.6 1.7 0
After Vaccination 1,Drowsiness: Moderate Number Analyzed 27 participants 56 participants 59 participants 29 participants
0 0 1.7 0
After Vaccination 3,Drowsiness: Severe Number Analyzed 27 participants 56 participants 59 participants 29 participants
0 0 0 3.4
After Vaccination 3,Loss of Appetite: Any Number Analyzed 27 participants 56 participants 59 participants 29 participants
7.4 12.5 3.4 10.3
After Vaccination 3, Loss of Appetite: Mild Number Analyzed 27 participants 56 participants 59 participants 29 participants
3.7 7.1 3.4 6.9
After Vaccination 3, Loss of Appetite: Moderate Number Analyzed 27 participants 56 participants 59 participants 29 participants
3.7 5.4 0 3.4
After Vaccination 3, Fever: Any Number Analyzed 26 participants 55 participants 60 participants 29 participants
0 3.6 3.3 6.9
After Vaccination 3, Fever (38.0 - < 38.5 °C) Number Analyzed 26 participants 55 participants 60 participants 29 participants
0 0 1.7 3.4
After Vaccination 3, Fever (38.5 - < 39.0 °C) Number Analyzed 26 participants 55 participants 60 participants 29 participants
0 1.8 1.7 0
After Vaccination 3, Fever (39.0 - < 39.5 °C) Number Analyzed 26 participants 55 participants 60 participants 29 participants
0 1.8 0 3.4
6.Secondary Outcome
Title Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination
Hide Description Solicited systemic AEs were collected by participants within 14 days after vaccination and included headache, asthenia, malaise, myalgia and fever. Severity scales for headache were none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents normal activity with or without treatment. Severity scales for others were none, mild: no interference with daily activity, moderate: interference with daily activity and severe: prevents daily activity. A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it.
Time Frame Within 14 days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Only participants in immunogenicity subset were included. Data were summarized separately for each age group. Number analyzed are participants with data available for the category. Only categories for which there was at least 1 participant are reported.
Arm/Group Title Group 1 (TDV 2-Dose) Adult/Children Group 2 (TDV 1-Dose) Adult/Children Group 3 (TDV 1-Dose + Booster) Adult/Children Group 4 (Placebo Control) Adult/Children
Hide Arm/Group Description:
Participants aged ≥6 years received Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.
Participants aged ≥6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.
Participants aged ≥6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.
Participants aged ≥6 years received placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
Overall Number of Participants Analyzed 62 127 129 61
Measure Type: Number
Unit of Measure: percentage of participants
After Vaccination 1, Headache: Any Number Analyzed 60 participants 126 participants 123 participants 57 participants
20.0 23.8 16.3 21.1
After Vaccination 1, Headache: Mild Number Analyzed 60 participants 126 participants 123 participants 57 participants
16.7 20.6 13.0 14.0
After Vaccination 1, Headache: Moderate Number Analyzed 60 participants 126 participants 123 participants 57 participants
3.3 2.4 1.6 5.3
After Vaccination 1, Headache: Severe Number Analyzed 60 participants 126 participants 123 participants 57 participants
0 0.8 1.6 1.8
After Vaccination 1, Asthenia: Any Number Analyzed 60 participants 126 participants 123 participants 57 participants
5.0 11.1 7.3 7.0
After Vaccination 1, Asthenia: Mild Number Analyzed 60 participants 126 participants 123 participants 57 participants
3.3 10.3 4.9 3.5
After Vaccination 1, Asthenia: Moderate Number Analyzed 60 participants 126 participants 123 participants 57 participants
1.7 0.8 1.6 3.5
After Vaccination 1, Asthenia: Severe Number Analyzed 60 participants 126 participants 123 participants 57 participants
0 0 0.8 0
After Vaccination 1, Malaise: Any Number Analyzed 60 participants 126 participants 123 participants 57 participants
8.3 14.3 8.9 10.5
After Vaccination 1, Malaise: Mild Number Analyzed 60 participants 126 participants 123 participants 57 participants
6.7 13.5 7.3 8.8
After Vaccination 1, Malaise: Moderate Number Analyzed 60 participants 126 participants 123 participants 57 participants
1.7 0.8 0.8 0
After Vaccination 1, Malaise: Severe Number Analyzed 60 participants 126 participants 123 participants 57 participants
0 0 0.8 1.8
After Vaccination 1, Myalgia: Any Number Analyzed 60 participants 126 participants 123 participants 57 participants
10.0 20.6 11.4 7.0
After Vaccination 1, Myalgia: Mild Number Analyzed 60 participants 126 participants 123 participants 57 participants
8.3 18.3 10.6 7.0
After Vaccination 1, Myalgia: Moderate Number Analyzed 60 participants 126 participants 123 participants 57 participants
1.7 2.4 0 0
After Vaccination 1, Myalgia: Severe Number Analyzed 60 participants 126 participants 123 participants 57 participants
0 0 0.8 0
After Vaccination 1, Fever: Any Number Analyzed 51 participants 119 participants 110 participants 51 participants
5.9 2.5 4.5 5.9
After Vaccination 1, Fever: 38.0 - < 38.5 °C Number Analyzed 51 participants 119 participants 110 participants 51 participants
2.0 1.7 0 2.0
After Vaccination 1, Fever: 38.5 - < 39.0 °C Number Analyzed 51 participants 119 participants 110 participants 51 participants
2.0 0 1.8 3.9
After Vaccination 1, Fever: 39.0 - < 39.5 °C Number Analyzed 51 participants 119 participants 110 participants 51 participants
2.0 0.8 0.9 0
After Vaccination 1, Fever: 39.5 - < 40.0 °C Number Analyzed 51 participants 119 participants 110 participants 51 participants
0 0 1.8 0
After Vaccination 2, Headache: Any Number Analyzed 59 participants 115 participants 118 participants 55 participants
18.6 9.6 6.8 16.4
After Vaccination 2, Headache: Mild Number Analyzed 59 participants 115 participants 118 participants 55 participants
11.9 7.8 4.2 12.7
After Vaccination 2, Headache: Moderate Number Analyzed 59 participants 115 participants 118 participants 55 participants
5.1 0.9 2.5 1.8
After Vaccination 2, Headache: Severe Number Analyzed 59 participants 115 participants 118 participants 55 participants
1.7 0.9 0 1.8
After Vaccination 2, Asthenia: Any Number Analyzed 59 participants 115 participants 118 participants 55 participants
8.5 7.8 4.2 3.6
After Vaccination 2, Asthenia: Mild Number Analyzed 59 participants 115 participants 118 participants 55 participants
5.1 7.0 2.5 3.6
After Vaccination 2, Asthenia: Moderate Number Analyzed 59 participants 115 participants 118 participants 55 participants
1.7 0 1.7 0
After Vaccination 2, Asthenia: Severe Number Analyzed 59 participants 115 participants 118 participants 55 participants
1.7 0.9 0 0
After Vaccination 2, Malaise: Any Number Analyzed 59 participants 115 participants 118 participants 55 participants
15.3 8.7 6.8 9.1
After Vaccination 2, Malaise: Mild Number Analyzed 59 participants 115 participants 118 participants 55 participants
10.2 6.1 4.2 7.3
After Vaccination 2, Malaise: Moderate Number Analyzed 59 participants 115 participants 118 participants 55 participants
3.4 1.7 1.7 0
After Vaccination 2, Malaise: Severe Number Analyzed 59 participants 115 participants 118 participants 55 participants
1.7 0.9 0.8 1.8
After Vaccination 2, Myalgia: Any Number Analyzed 59 participants 115 participants 118 participants 55 participants
16.9 5.2 5.9 5.5
After Vaccination 2, Myalgia: Mild Number Analyzed 59 participants 115 participants 118 participants 55 participants
10.2 5.2 2.5 5.5
After Vaccination 2, Myalgia: Moderate Number Analyzed 59 participants 115 participants 118 participants 55 participants
3.4 0 2.5 0
After Vaccination 2, Myalgia: Severe Number Analyzed 59 participants 115 participants 118 participants 55 participants
3.4 0 0.8 0
After Vaccination 2, Fever: Any Number Analyzed 51 participants 104 participants 110 participants 49 participants
2.0 2.9 2.7 4.1
After Vaccination 2, Fever: 38.0 - < 38.5 °C Number Analyzed 51 participants 104 participants 110 participants 49 participants
2.0 1.0 0.9 0
After Vaccination 2, Fever: 38.5 - < 39.0 °C Number Analyzed 51 participants 104 participants 110 participants 49 participants
0 1.0 0.9 2.0
After Vaccination 2, Fever: 39.5 - < 40.0 °C Number Analyzed 51 participants 104 participants 110 participants 49 participants
0 1.0 0.9 2.0
After Vaccination 3, Headache: Any Number Analyzed 59 participants 115 participants 120 participants 55 participants
10.2 11.3 7.5 7.3
After Vaccination 3, Headache: Mild Number Analyzed 59 participants 115 participants 120 participants 55 participants
10.2 7.8 5.8 5.5
After Vaccination 3, Headache: Moderate Number Analyzed 59 participants 115 participants 120 participants 55 participants
0 1.7 1.7 0
After Vaccination 3, Headache: Severe Number Analyzed 59 participants 115 participants 120 participants 55 participants
0 1.7 0 1.8
After Vaccination 3, Asthenia: Any Number Analyzed 59 participants 115 participants 120 participants 55 participants
6.8 7.0 2.5 7.3
After Vaccination 3, Asthenia: Mild Number Analyzed 59 participants 115 participants 120 participants 55 participants
6.8 5.2 2.5 7.3
After Vaccination 3, Asthenia: Moderate Number Analyzed 59 participants 115 participants 120 participants 55 participants
0 0.9 0 0
After Vaccination 3, Asthenia: Severe Number Analyzed 59 participants 115 participants 120 participants 55 participants
0 0.9 0 0
After Vaccination 3, Malaise: Any Number Analyzed 59 participants 115 participants 120 participants 55 participants
5.1 7.8 8.3 3.6
After Vaccination 3, Malaise: Mild Number Analyzed 59 participants 115 participants 120 participants 55 participants
3.4 5.2 5.8 1.8
After Vaccination 3, Malaise: Moderate Number Analyzed 59 participants 115 participants 120 participants 55 participants
0 0.9 1.7 1.8
After Vaccination 3, Malaise: Severe Number Analyzed 59 participants 115 participants 120 participants 55 participants
1.7 1.7 0.8 0
After Vaccination 3, Myalgia: Any Number Analyzed 59 participants 115 participants 120 participants 55 participants
6.8 11.3 8.3 5.5
After Vaccination 3, Myalgia: Mild Number Analyzed 59 participants 115 participants 120 participants 55 participants
5.1 9.6 5.8 5.5
After Vaccination 3, Myalgia: Moderate Number Analyzed 59 participants 115 participants 120 participants 55 participants
0 0.9 1.7 0
After Vaccination 3, Myalgia: Severe Number Analyzed 59 participants 115 participants 120 participants 55 participants
1.7 0.9 0.8 0
After Vaccination 3, Fever: Any Number Analyzed 56 participants 106 participants 115 participants 51 participants
1.8 1.9 1.7 2.0
After Vaccination 3, Fever: 38.0 - < 38.5 °C Number Analyzed 56 participants 106 participants 115 participants 51 participants
0 1.9 0.9 2.0
After Vaccination 3, Fever: 38.5 - < 39.0 °C Number Analyzed 56 participants 106 participants 115 participants 51 participants
0 0 0.9 0
After Vaccination 3, Fever: 39.0 - < 39.5 °C Number Analyzed 56 participants 106 participants 115 participants 51 participants
1.8 0 0 0
7.Secondary Outcome
Title Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following Each Vaccination
Hide Description An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
Time Frame Within 28 days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Safety Set included only participants from Immunogenicity Subset with data available for analyses. Number analyzed is number of participants with data available after each vaccination.
Arm/Group Title Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control)
Hide Arm/Group Description:
Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.
Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.
Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.
Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
Overall Number of Participants Analyzed 91 187 191 93
Measure Type: Number
Unit of Measure: percentage of participants
After Vaccination 1 Number Analyzed 91 participants 187 participants 191 participants 93 participants
19.8 20.3 19.4 21.5
After Vaccination 2 Number Analyzed 90 participants 176 participants 181 participants 87 participants
12.2 10.2 11.0 16.1
After Vaccination 3 Number Analyzed 88 participants 172 participants 179 participants 84 participants
6.8 12.8 10.1 9.5
8.Secondary Outcome
Title Percentage of Participants With Serious Adverse Events (SAEs)
Hide Description An SAE was defined as any untoward medical occurrence or effect that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above-mentioned criteria.
Time Frame From first vaccination through end of study (Day 1460)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of trial vaccine.
Arm/Group Title Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control)
Hide Arm/Group Description:
Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.
Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.
Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.
Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
Overall Number of Participants Analyzed 200 398 998 198
Measure Type: Number
Unit of Measure: percentage of participants
5.0 4.5 6.5 5.1
9.Secondary Outcome
Title Percentage of Participants With Febrile Episodes of Virologically Confirmed Dengue With Onset 30 Days Post-first Vaccination
Hide Description Participants with febrile illness (defined as temperature ≥ 38°C on 2 consecutive days) were evaluated for dengue. A dengue infection was considered virologically confirmed by either positive polymerase chain reaction (PCR) or NS1 enzyme-linked immunosorbent assay (ELISA). Virologically confirmed dengue with onset 30 days after first vaccination within each group.
Time Frame From 30 days post-first vaccination through end of study (Day 1460)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least 1 dose of trial vaccine.
Arm/Group Title Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control)
Hide Arm/Group Description:
Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.
Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.
Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.
Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
Overall Number of Participants Analyzed 200 398 998 198
Measure Type: Number
Unit of Measure: percentage of participants
3.5 2.0 2.2 6.6
Time Frame All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 540); Other adverse events: From any vaccination (Day 1, Day 91, and Day 365) up to 28 days post vaccination.
Adverse Event Reporting Description Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Data for other (non-serious) adverse events is reported for participants from Immunogenicity Subset with available data for analyses.
 
Arm/Group Title Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control)
Hide Arm/Group Description Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365. Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365. Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91. Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
All-Cause Mortality
Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/200 (0.00%)   1/398 (0.25%)   1/998 (0.10%)   0/198 (0.00%) 
Hide Serious Adverse Events
Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/200 (5.00%)   18/398 (4.52%)   65/998 (6.51%)   10/198 (5.05%) 
Blood and lymphatic system disorders         
Immune Thrombocytopenic Purpura  1  1/200 (0.50%)  0/398 (0.00%)  0/998 (0.00%)  0/198 (0.00%) 
Eye disorders         
Ocular Myasthenia  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Gastrointestinal disorders         
Constipation  1  0/200 (0.00%)  1/398 (0.25%)  1/998 (0.10%)  0/198 (0.00%) 
Vomiting  1  0/200 (0.00%)  0/398 (0.00%)  2/998 (0.20%)  0/198 (0.00%) 
Diarrhoea  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Gastritis  1  0/200 (0.00%)  1/398 (0.25%)  0/998 (0.00%)  0/198 (0.00%) 
Ileus Paralytic  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Inguinal Hernia  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Intestinal Obstruction  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Volvulus  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
General disorders         
Dehiscence  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Immune system disorders         
Food Allergy  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Hypersensitivity  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Infections and infestations         
Amoebic Dysentery  1  1/200 (0.50%)  1/398 (0.25%)  5/998 (0.50%)  1/198 (0.51%) 
Gastroenteritis  1  0/200 (0.00%)  2/398 (0.50%)  5/998 (0.50%)  1/198 (0.51%) 
Appendicitis  1  2/200 (1.00%)  0/398 (0.00%)  4/998 (0.40%)  0/198 (0.00%) 
Pneumonia  1  0/200 (0.00%)  1/398 (0.25%)  5/998 (0.50%)  0/198 (0.00%) 
Urinary Tract Infection  1  0/200 (0.00%)  1/398 (0.25%)  4/998 (0.40%)  0/198 (0.00%) 
Abscess Limb  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  1/198 (0.51%) 
Ascariasis  1  0/200 (0.00%)  1/398 (0.25%)  1/998 (0.10%)  0/198 (0.00%) 
Dengue Fever  1  0/200 (0.00%)  1/398 (0.25%)  1/998 (0.10%)  0/198 (0.00%) 
Scarlet Fever  1  0/200 (0.00%)  0/398 (0.00%)  2/998 (0.20%)  0/198 (0.00%) 
Amoebiasis  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Appendicitis Perforated  1  0/200 (0.00%)  0/398 (0.00%)  0/998 (0.00%)  1/198 (0.51%) 
Bronchitis  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Burkholderia Cepacia Complex Sepsis  1  0/200 (0.00%)  0/398 (0.00%)  0/998 (0.00%)  1/198 (0.51%) 
Encephalomyelitis  1  0/200 (0.00%)  1/398 (0.25%)  0/998 (0.00%)  0/198 (0.00%) 
Endometritis  1  1/200 (0.50%)  0/398 (0.00%)  0/998 (0.00%)  0/198 (0.00%) 
Gastroenteritis Rotavirus  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Hepatitis A  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Infectious Colitis  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Nasal Abscess  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Osteomyelitis  1  0/200 (0.00%)  0/398 (0.00%)  0/998 (0.00%)  1/198 (0.51%) 
Peritonitis  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Peritonsillar Abscess  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Pharyngotonsillitis  1  0/200 (0.00%)  1/398 (0.25%)  0/998 (0.00%)  0/198 (0.00%) 
Pulmonary Tuberculosis  1  0/200 (0.00%)  1/398 (0.25%)  0/998 (0.00%)  0/198 (0.00%) 
Pyelonephritis  1  0/200 (0.00%)  0/398 (0.00%)  0/998 (0.00%)  1/198 (0.51%) 
Respiratory Tract Infection  1  0/200 (0.00%)  1/398 (0.25%)  0/998 (0.00%)  0/198 (0.00%) 
Sepsis  1  0/200 (0.00%)  1/398 (0.25%)  0/998 (0.00%)  0/198 (0.00%) 
Septic Shock  1  0/200 (0.00%)  1/398 (0.25%)  0/998 (0.00%)  0/198 (0.00%) 
Sinusitis  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Tonsillitis  1  1/200 (0.50%)  0/398 (0.00%)  0/998 (0.00%)  0/198 (0.00%) 
Tooth Abscess  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Viral Infection  1  0/200 (0.00%)  0/398 (0.00%)  0/998 (0.00%)  1/198 (0.51%) 
Injury, poisoning and procedural complications         
Contusion  1  0/200 (0.00%)  1/398 (0.25%)  2/998 (0.20%)  0/198 (0.00%) 
Head Injury  1  1/200 (0.50%)  0/398 (0.00%)  2/998 (0.20%)  0/198 (0.00%) 
Multiple Injuries  1  0/200 (0.00%)  0/398 (0.00%)  3/998 (0.30%)  0/198 (0.00%) 
Abdominal Injury  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Ankle Fracture  1  1/200 (0.50%)  0/398 (0.00%)  0/998 (0.00%)  0/198 (0.00%) 
Arthropod Bite  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Arthropod Sting  1  0/200 (0.00%)  0/398 (0.00%)  0/998 (0.00%)  1/198 (0.51%) 
Burns Second Degree  1  0/200 (0.00%)  1/398 (0.25%)  0/998 (0.00%)  0/198 (0.00%) 
Facial Bones Fracture  1  1/200 (0.50%)  0/398 (0.00%)  0/998 (0.00%)  0/198 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  1/200 (0.50%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Musculoskeletal and connective tissue disorders         
Aneurysmal Bone Cyst  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Teratoma Benign  1  1/200 (0.50%)  0/398 (0.00%)  0/998 (0.00%)  0/198 (0.00%) 
Nervous system disorders         
Seizure  1  0/200 (0.00%)  0/398 (0.00%)  2/998 (0.20%)  0/198 (0.00%) 
Epilepsy  1  0/200 (0.00%)  1/398 (0.25%)  0/998 (0.00%)  0/198 (0.00%) 
Generalised Tonic-Clonic  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Headache  1  0/200 (0.00%)  1/398 (0.25%)  0/998 (0.00%)  0/198 (0.00%) 
Migraine  1  0/200 (0.00%)  1/398 (0.25%)  0/998 (0.00%)  0/198 (0.00%) 
Relapsing-Remitting Multiple Sclerosis  1  0/200 (0.00%)  1/398 (0.25%)  0/998 (0.00%)  0/198 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Abortion Spontaneous  1  0/200 (0.00%)  1/398 (0.25%)  0/998 (0.00%)  0/198 (0.00%) 
Premature Baby  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Renal and urinary disorders         
Glomerulonephritis Acute  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Nephritic Syndrome  1  0/200 (0.00%)  0/398 (0.00%)  0/998 (0.00%)  1/198 (0.51%) 
Reproductive system and breast disorders         
Ovarian Cyst  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Ovarian Cyst Torsion  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthmatic Crisis  1  0/200 (0.00%)  1/398 (0.25%)  4/998 (0.40%)  0/198 (0.00%) 
Asthma  1  0/200 (0.00%)  0/398 (0.00%)  2/998 (0.20%)  1/198 (0.51%) 
Bronchospasm  1  0/200 (0.00%)  1/398 (0.25%)  0/998 (0.00%)  0/198 (0.00%) 
Social circumstances         
Homicide  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
Surgical and medical procedures         
Finger Amputation  1  0/200 (0.00%)  0/398 (0.00%)  1/998 (0.10%)  0/198 (0.00%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/91 (18.68%)   43/187 (22.99%)   41/191 (21.47%)   22/93 (23.66%) 
Gastrointestinal disorders         
Diarrhoea  1  1/91 (1.10%)  4/187 (2.14%)  2/191 (1.05%)  2/93 (2.15%) 
Vomiting  1  1/91 (1.10%)  3/187 (1.60%)  0/191 (0.00%)  3/93 (3.23%) 
General disorders         
Pyrexia  1  2/91 (2.20%)  1/187 (0.53%)  2/191 (1.05%)  1/93 (1.08%) 
Immune system disorders         
Hypersensitivity  1  0/91 (0.00%)  0/187 (0.00%)  2/191 (1.05%)  2/93 (2.15%) 
Infections and infestations         
Nasopharyngitis  1  10/91 (10.99%)  25/187 (13.37%)  21/191 (10.99%)  10/93 (10.75%) 
Viral Infection  1  1/91 (1.10%)  4/187 (2.14%)  4/191 (2.09%)  2/93 (2.15%) 
Bronchitis  1  0/91 (0.00%)  4/187 (2.14%)  3/191 (1.57%)  0/93 (0.00%) 
Tonsillitis  1  2/91 (2.20%)  3/187 (1.60%)  2/191 (1.05%)  0/93 (0.00%) 
Parasitic Gastroenteritis  1  2/91 (2.20%)  0/187 (0.00%)  1/191 (0.52%)  2/93 (2.15%) 
Gastroenteritis  1  1/91 (1.10%)  7/187 (3.74%)  5/191 (2.62%)  5/93 (5.38%) 
Nervous system disorders         
Headache  1  1/91 (1.10%)  2/187 (1.07%)  5/191 (2.62%)  1/93 (1.08%) 
Respiratory, thoracic and mediastinal disorders         
Nasal Congestion  1  0/91 (0.00%)  1/187 (0.53%)  0/191 (0.00%)  2/93 (2.15%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02302066    
Other Study ID Numbers: DEN-204
PHRR140804-000219 ( Registry Identifier: PHRR )
U1111-1154-2475 ( Registry Identifier: WHO )
2018-003978-28 ( Registry Identifier: EudraCT )
First Submitted: November 24, 2014
First Posted: November 26, 2014
Results First Submitted: February 10, 2020
Results First Posted: February 24, 2020
Last Update Posted: February 24, 2020