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Immunologic Mechanisms of Immune Interference and/or Cross-Neutralizing Immunity After CYD Tetravalent Dengue Vaccine

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ClinicalTrials.gov Identifier: NCT01943825
Recruitment Status : Completed
First Posted : September 17, 2013
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Dengue
Dengue Fever
Dengue Hemorrhagic Fever
Interventions Biological: CYD Dengue Vaccine
Biological: Japanese Encephalitis Vaccine
Enrollment 90
Recruitment Details Participants were involved in the study from 05 November 2013 to 25 November 2015 in the United States.
Pre-assignment Details A total of 90 participants were enrolled and randomized in the study.
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and Japanese Encephalitis (JE) Vaccine : Group 3 CYD Dengue and JE Vaccine: Group 4
Hide Arm/Group Description Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively. Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively. Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively. Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
Period Title: Overall Study
Started 25 15 25 25
Completed 15 11 10 14
Not Completed 10 4 15 11
Reason Not Completed
Lost to Follow-up             9             3             12             8
Withdrawal by Subject             1             0             3             2
Other than specified above             0             1             0             1
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and JE Vaccine : Group 3 CYD Dengue and JE Vaccine: Group 4 Total
Hide Arm/Group Description Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively. Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively. Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively. Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively. Total of all reporting groups
Overall Number of Baseline Participants 25 15 25 25 90
Hide Baseline Analysis Population Description
Analysis was performed on safety analysis set which included all participants who received at least one dose of CYD dengue vaccine or JE vaccine.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 15 participants 25 participants 25 participants 90 participants
31.0  (6.7) 26.8  (5.6) 28.5  (6.5) 30.4  (6.2) 29.4  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 15 participants 25 participants 25 participants 90 participants
Female
12
  48.0%
6
  40.0%
7
  28.0%
12
  48.0%
37
  41.1%
Male
13
  52.0%
9
  60.0%
18
  72.0%
13
  52.0%
53
  58.9%
1.Primary Outcome
Title Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
Hide Description GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by plaque reduction neutralization test (PRNT). The lower limit of quantitation (LLOQ) of the assay was a titer of 10 (1/dilution).
Time Frame Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on full analysis set which included participants who received at least one injection of CYD dengue vaccine or JE vaccine and had at least one blood sample drawn and valid post-injection serology result. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and JE Vaccine : Group 3 CYD Dengue and JE Vaccine: Group 4
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
Overall Number of Participants Analyzed 25 15 25 25
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers (1/dilution)
Serotype 1: Pre-injection 1 Number Analyzed 25 participants 15 participants 25 participants 19 participants
NA [1] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
Serotype 1: 28 days Post-injection 1 Number Analyzed 24 participants 14 participants 19 participants 19 participants
6.1
(4.8 to 7.8)
5.5
(4.5 to 6.8)
6.8
(4.7 to 10.0)
7.4
(5.3 to 10.2)
Serotype 1: Pre-injection 2 Number Analyzed 22 participants 14 participants 17 participants 18 participants
6.5
(4.7 to 8.9)
5.4
(4.6 to 6.4)
6.7
(4.3 to 10.6)
7.2
(5.0 to 10.2)
Serotype 1: 28 days Post-injection 2 Number Analyzed 18 participants 13 participants 15 participants 18 participants
8.5
(5.5 to 13.1)
6.2
(4.5 to 8.4)
10.8
(5.4 to 21.8)
10.8
(6.6 to 17.7)
Serotype 1: Pre-injection 3 Number Analyzed 18 participants 12 participants 15 participants 16 participants
7.1
(4.7 to 10.8)
6.3
(4.4 to 9.0)
8.3
(4.6 to 15.1)
6.5
(4.7 to 9.1)
Serotype 1: 28 days Post-injection 3 Number Analyzed 17 participants 12 participants 14 participants 16 participants
9.1
(5.5 to 15.0)
9.9
(6.0 to 16.6)
12.0
(5.4 to 26.7)
12.9
(7.6 to 21.9)
Serotype 1: 6 months Post-injection 3 Number Analyzed 17 participants 11 participants 10 participants 14 participants
5.8
(4.7 to 7.3)
6.6
(4.3 to 9.9)
8.6
(3.5 to 21.1)
7.3
(5.0 to 10.9)
Serotype 2: Pre-injection 1 Number Analyzed 25 participants 15 participants 25 participants 19 participants
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
Serotype 2: 28 days Post-injection 1 Number Analyzed 24 participants 14 participants 19 participants 19 participants
9.2
(5.3 to 16.1)
7.4
(4.1 to 13.1)
8.8
(5.0 to 15.6)
35.5
(21.2 to 59.5)
Serotype 2: Pre-injection 2 Number Analyzed 22 participants 14 participants 17 participants 18 participants
12.1
(5.3 to 27.4)
9.6
(5.8 to 15.9)
8.8
(4.8 to 16.1)
44.5
(23.1 to 85.7)
Serotype 2: 28 days Post-injection 2 Number Analyzed 18 participants 13 participants 15 participants 18 participants
19.0
(8.8 to 41.1)
10.7
(5.7 to 19.9)
17.3
(7.6 to 39.7)
61.5
(30.4 to 124.6)
Serotype 2: Pre-injection 3 Number Analyzed 18 participants 12 participants 15 participants 16 participants
13.3
(6.7 to 26.4)
9.8
(5.1 to 18.8)
12.2
(6.7 to 22.2)
37.4
(16.1 to 87.1)
Serotype 2: 28 days Post-injection 3 Number Analyzed 17 participants 12 participants 14 participants 16 participants
32.5
(14.3 to 73.9)
25.5
(13.0 to 50.0)
19.3
(9.8 to 37.9)
48.2
(22.4 to 103.5)
Serotype 2: 6 months Post-injection 3 Number Analyzed 17 participants 11 participants 10 participants 14 participants
13.9
(6.7 to 29.0)
7.9
(4.4 to 14.3)
10.9
(4.6 to 26.0)
21.0
(9.2 to 48.2)
Serotype 3: Pre-injection 1 Number Analyzed 25 participants 15 participants 25 participants 19 participants
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
5.2
(4.8 to 5.6)
NA [2] 
(NA to NA)
Serotype 3: 28 days Post-injection 1 Number Analyzed 24 participants 14 participants 19 participants 19 participants
22.1
(12.1 to 40.5)
24.9
(8.5 to 72.9)
19.7
(8.8 to 44.1)
49.3
(24.9 to 97.5)
Serotype 3: Pre-injection 2 Number Analyzed 22 participants 14 participants 17 participants 18 participants
24.5
(10.7 to 56.4)
15.4
(7.5 to 31.6)
23.8
(10.8 to 52.4)
49.0
(22.9 to 104.8)
Serotype 3: 28 days Post-injection 2 Number Analyzed 18 participants 13 participants 15 participants 18 participants
31.0
(15.0 to 63.7)
40.8
(14.7 to 113.3)
28.5
(12.4 to 65.4)
68.8
(36.9 to 128.3)
Serotype 3: Pre-injection 3 Number Analyzed 18 participants 12 participants 15 participants 16 participants
22.9
(12.1 to 43.2)
31.7
(13.9 to 72.0)
20.5
(9.5 to 44.1)
35.6
(17.8 to 71.6)
Serotype 3: 28 days Post-injection 3 Number Analyzed 17 participants 12 participants 14 participants 16 participants
45.5
(24.4 to 84.8)
79.9
(44.1 to 144.6)
32.2
(12.9 to 80.7)
61.8
(39.3 to 97.1)
Serotype 3: 6 months Post-injection 3 Number Analyzed 17 participants 11 participants 10 participants 14 participants
19.3
(10.2 to 36.6)
33.9
(13.9 to 82.5)
19.3
(7.5 to 49.5)
24.8
(12.6 to 48.7)
Serotype 4: Pre-injection 1 Number Analyzed 25 participants 15 participants 25 participants 19 participants
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
NA [2] 
(NA to NA)
Serotype 4: 28 days Post-injection 1 Number Analyzed 24 participants 14 participants 19 participants 19 participants
425.8
(172.1 to 1053.4)
669.7
(188.3 to 2381.8)
177.6
(62.1 to 508.1)
325.4
(147.8 to 716.3)
Serotype 4: Pre-injection 2 Number Analyzed 22 participants 14 participants 17 participants 18 participants
296.2
(151.9 to 577.6)
100.3
(51.7 to 194.6)
89.9
(24.8 to 326.2)
300.9
(144.4 to 627.0)
Serotype 4: 28 days Post-injection 2 Number Analyzed 18 participants 13 participants 15 participants 18 participants
166.6
(90.2 to 307.7)
147.1
(91.8 to 235.7)
68.0
(23.4 to 197.1)
211.3
(103.3 to 432.2)
Serotype 4: Pre-injection 3 Number Analyzed 18 participants 12 participants 15 participants 16 participants
108.9
(63.5 to 186.6)
89.8
(49.2 to 163.9)
47.7
(18.4 to 123.9)
139.5
(65.8 to 295.4)
Serotype 4: 28 days Post-injection 3 Number Analyzed 17 participants 12 participants 14 participants 16 participants
120.4
(67.2 to 215.7)
124.5
(78.2 to 198.1)
55.4
(22.5 to 136.8)
152.5
(75.3 to 308.6)
Serotype 4: 6 months Post-injection 3 Number Analyzed 17 participants 11 participants 10 participants 14 participants
105.3
(52.5 to 211.1)
106.7
(71.7 to 158.8)
43.8
(13.3 to 144.3)
92.6
(56.7 to 151.1)
[1]
Participants had a titer reported as less than (<) LLOQ.
[2]
Participants had a titer reported as < LLOQ.
2.Primary Outcome
Title Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Hide Description Antibody titers against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT.
Time Frame Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on full analysis set. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and JE Vaccine : Group 3 CYD Dengue and JE Vaccine: Group 4
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccines at 0 and 1 months, respectively.
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
Overall Number of Participants Analyzed 25 15 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
Serotype 1: Pre-injection 1 Number Analyzed 25 participants 15 participants 25 participants 19 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Serotype 1: 28 days Post-injection 1 Number Analyzed 24 participants 14 participants 19 participants 19 participants
3
  12.5%
1
   7.1%
3
  15.8%
6
  31.6%
Serotype 1: Pre-injection 2 Number Analyzed 22 participants 14 participants 17 participants 18 participants
3
  13.6%
1
   7.1%
2
  11.8%
4
  22.2%
Serotype 1: 28 days Post-injection 2 Number Analyzed 18 participants 13 participants 15 participants 18 participants
6
  33.3%
2
  15.4%
5
  33.3%
8
  44.4%
Serotype 1: Pre-injection 3 Number Analyzed 18 participants 12 participants 15 participants 16 participants
3
  16.7%
2
  16.7%
3
  20.0%
3
  18.8%
Serotype 1: 28 days Post-injection 3 Number Analyzed 17 participants 12 participants 14 participants 16 participants
5
  29.4%
6
  50.0%
5
  35.7%
9
  56.3%
Serotype 1: 6 months Post-injection 3 Number Analyzed 17 participants 11 participants 10 participants 14 participants
2
  11.8%
2
  18.2%
2
  20.0%
4
  28.6%
Serotype 2: Pre-injection 1 Number Analyzed 25 participants 15 participants 25 participants 19 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Serotype 2: 28 days Post-injection 1 Number Analyzed 24 participants 14 participants 19 participants 19 participants
5
  20.8%
2
  14.3%
4
  21.1%
16
  84.2%
Serotype 2: Pre-injection 2 Number Analyzed 22 participants 14 participants 17 participants 18 participants
5
  22.7%
7
  50.0%
4
  23.5%
15
  83.3%
Serotype 2: 28 days Post-injection 2 Number Analyzed 18 participants 13 participants 15 participants 18 participants
9
  50.0%
5
  38.5%
7
  46.7%
16
  88.9%
Serotype 2: Pre-injection 3 Number Analyzed 18 participants 12 participants 15 participants 16 participants
8
  44.4%
4
  33.3%
7
  46.7%
13
  81.3%
Serotype 2: 28 days Post-injection 3 Number Analyzed 17 participants 12 participants 14 participants 16 participants
12
  70.6%
9
  75.0%
9
  64.3%
15
  93.8%
Serotype 2: 6 months Post-injection 3 Number Analyzed 17 participants 11 participants 10 participants 14 participants
7
  41.2%
3
  27.3%
4
  40.0%
9
  64.3%
Serotype 3: Pre-injection 1 Number Analyzed 25 participants 15 participants 25 participants 19 participants
0
   0.0%
0
   0.0%
1
   4.0%
0
   0.0%
Serotype 3: 28 days Post-injection 1 Number Analyzed 24 participants 14 participants 19 participants 19 participants
15
  62.5%
7
  50.0%
10
  52.6%
16
  84.2%
Serotype 3: Pre-injection 2 Number Analyzed 22 participants 14 participants 17 participants 18 participants
11
  50.0%
7
  50.0%
10
  58.8%
14
  77.8%
Serotype 3: 28 days Post-injection 2 Number Analyzed 18 participants 13 participants 15 participants 18 participants
12
  66.7%
9
  69.2%
10
  66.7%
16
  88.9%
Serotype 3: Pre-injection 3 Number Analyzed 18 participants 12 participants 15 participants 16 participants
12
  66.7%
10
  83.3%
9
  60.0%
12
  75.0%
Serotype 3: 28 days Post-injection 3 Number Analyzed 17 participants 12 participants 14 participants 16 participants
14
  82.4%
12
 100.0%
9
  64.3%
16
 100.0%
Serotype 3: 6 months Post-injection 3 Number Analyzed 17 participants 11 participants 10 participants 14 participants
10
  58.8%
9
  81.8%
6
  60.0%
10
  71.4%
Serotype 4: Pre-injection 1 Number Analyzed 25 participants 15 participants 25 participants 19 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Serotype 4: 28 days Post-injection 1 Number Analyzed 24 participants 14 participants 19 participants 19 participants
21
  87.5%
13
  92.9%
16
  84.2%
18
  94.7%
Serotype 4: Pre-injection 2 Number Analyzed 22 participants 14 participants 17 participants 18 participants
21
  95.5%
13
  92.9%
11
  64.7%
18
 100.0%
Serotype 4: 28 days Post-injection 2 Number Analyzed 18 participants 13 participants 15 participants 18 participants
17
  94.4%
13
 100.0%
11
  73.3%
18
 100.0%
Serotype 4: Pre-injection 3 Number Analyzed 18 participants 12 participants 15 participants 16 participants
17
  94.4%
12
 100.0%
11
  73.3%
16
 100.0%
Serotype 4: 28 days Post-injection 3 Number Analyzed 17 participants 12 participants 14 participants 16 participants
16
  94.1%
12
 100.0%
11
  78.6%
16
 100.0%
Serotype 4: 6 months Post-injection 3 Number Analyzed 17 participants 11 participants 10 participants 14 participants
15
  88.2%
11
 100.0%
7
  70.0%
14
 100.0%
3.Secondary Outcome
Title Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
Hide Description GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT. The LLOQ of the assay was a titer of 10 (1/dilution).
Time Frame Pre-injection 1, 2 and 3, and 28 days post-injection 1, 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on full analysis set. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title CYD Dengue and JE Vaccine : Group 3 CYD Dengue and JE Vaccine: Group 4
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
Overall Number of Participants Analyzed 25 25
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers (1/dilution)
Serotype 1: Pre-injection 1 Number Analyzed 25 participants 19 participants
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Serotype 1: 28 days Post-injection 1 Number Analyzed 19 participants 19 participants
6.8
(4.7 to 10.0)
7.4
(5.3 to 10.2)
Serotype 1: Pre-injection 2 Number Analyzed 17 participants 18 participants
6.7
(4.3 to 10.6)
7.2
(5.0 to 10.2)
Serotype 1: 28 days Post-injection 2 Number Analyzed 15 participants 18 participants
10.8
(5.4 to 21.8)
10.8
(6.6 to 17.7)
Serotype 1: Pre-injection 3 Number Analyzed 15 participants 16 participants
8.3
(4.6 to 15.1)
6.5
(4.7 to 9.1)
Serotype 1: 28 days Post-injection 3 Number Analyzed 14 participants 16 participants
12.0
(5.4 to 26.7)
12.9
(7.6 to 21.9)
Serotype 2: Pre-injection 1 Number Analyzed 25 participants 19 participants
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Serotype 2: 28 days Post-injection 1 Number Analyzed 19 participants 19 participants
8.8
(5.0 to 15.6)
35.5
(21.2 to 59.5)
Serotype 2: Pre-injection 2 Number Analyzed 17 participants 18 participants
8.8
(4.8 to 16.1)
44.5
(23.1 to 85.7)
Serotype 2: 28 days Post-injection 2 Number Analyzed 15 participants 18 participants
17.3
(7.6 to 39.7)
61.5
(30.4 to 124.6)
Serotype 2: Pre-injection 3 Number Analyzed 15 participants 16 participants
12.2
(6.7 to 22.2)
37.4
(16.1 to 87.1)
Serotype 2: 28 days Post-injection 3 Number Analyzed 14 participants 16 participants
19.3
(9.8 to 37.9)
48.2
(22.4 to 103.5)
Serotype 3: Pre-injection 1 Number Analyzed 25 participants 19 participants
5.2
(4.8 to 5.6)
NA [1] 
(NA to NA)
Serotype 3: 28 days Post-injection 1 Number Analyzed 19 participants 19 participants
19.7
(8.8 to 44.1)
49.3
(24.9 to 97.5)
Serotype 3: Pre-injection 2 Number Analyzed 17 participants 18 participants
23.8
(10.8 to 52.4)
49.0
(22.9 to 104.8)
Serotype 3: 28 days Post-injection 2 Number Analyzed 15 participants 18 participants
28.5
(12.4 to 65.4)
68.8
(36.9 to 128.3)
Serotype 3: Pre-injection 3 Number Analyzed 15 participants 16 participants
20.5
(9.5 to 44.1)
35.6
(17.8 to 71.6)
Serotype 3: 28 days Post-injection 3 Number Analyzed 14 participants 16 participants
32.2
(12.9 to 80.7)
61.8
(39.3 to 97.1)
Serotype 4: Pre-injection 1 Number Analyzed 25 participants 19 participants
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Serotype 4: 28 days Post-injection 1 Number Analyzed 19 participants 19 participants
177.6
(62.1 to 508.1)
325.4
(147.8 to 716.3)
Serotype 4: Pre-injection 2 Number Analyzed 17 participants 18 participants
89.9
(24.8 to 326.2)
300.9
(144.4 to 627.0)
Serotype 4: 28 days Post-injection 2 Number Analyzed 15 participants 18 participants
68.0
(23.4 to 197.1)
211.3
(103.3 to 432.2)
Serotype 4: Pre-injection 3 Number Analyzed 15 participants 16 participants
47.7
(18.4 to 123.9)
139.5
(65.8 to 295.4)
Serotype 4: 28 days Post-injection 3 Number Analyzed 14 participants 16 participants
55.4
(22.5 to 136.8)
152.5
(75.3 to 308.6)
[1]
Participants had a titer reported as < LLOQ.
4.Secondary Outcome
Title Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains
Hide Description GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT.
Time Frame 6 months and 12 months post-injection 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on full analysis set. Here, 'Number analyzed' = participants with available data for each specified category. Data was not planned to be collected and analyzed for Groups 2 and 4 for 12 months post-injection 3 time point.
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and JE Vaccine : Group 3 CYD Dengue and JE Vaccine: Group 4
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
Overall Number of Participants Analyzed 25 15 25 25
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers (1/dilution)
Serotype 1: 6 months Post-injection 3 Number Analyzed 17 participants 11 participants 10 participants 14 participants
5.8
(4.7 to 7.3)
6.6
(4.3 to 9.9)
8.6
(3.5 to 12.1)
7.3
(5.0 to 10.9)
Serotype 2: 6 months Post-injection 3 Number Analyzed 17 participants 11 participants 10 participants 14 participants
13.9
(6.7 to 29.0)
7.9
(4.4 to 14.3)
10.9
(4.6 to 26.0)
21.0
(9.2 to 48.2)
Serotype 3: 6 months Post-injection 3 Number Analyzed 17 participants 11 participants 10 participants 14 participants
19.3
(10.2 to 36.6)
33.9
(13.9 to 82.5)
19.3
(7.5 to 49.5)
24.8
(12.6 to 48.7)
Serotype 4: 6 months Post-injection 3 Number Analyzed 17 participants 11 participants 10 participants 14 participants
105.3
(52.5 to 211.1)
106.7
(71.7 to 158.8)
43.8
(13.3 to 144.3)
92.6
(56.7 to 151.1)
Serotype 1: 12 months Post-injection 3 Number Analyzed 15 participants 0 participants 10 participants 0 participants
5.3
(4.7 to 6.0)
7.8
(4.2 to 14.5)
Serotype 2: 12 months Post-injection 3 Number Analyzed 15 participants 0 participants 10 participants 0 participants
11.5
(5.2 to 25.5)
7.6
(3.7 to 15.6)
Serotype 3: 12 months Post-injection 3 Number Analyzed 15 participants 0 participants 10 participants 0 participants
18.3
(9.5 to 35.2)
16.2
(5.8 to 45.0)
Serotype 4: 12 months Post-injection 3 Number Analyzed 15 participants 0 participants 10 participants 0 participants
144.8
(68.8 to 304.8)
23.9
(8.1 to 70.8)
5.Secondary Outcome
Title Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia
Hide Description Viremia was determined by reverse transcriptase (RT) polymerase chain reaction (PCR) using primer/probes specific to a non serotype-specific part of the dengue vaccine.
Time Frame 3, 5, 7 and 14 days post-injection 1, 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on full analysis set. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and JE Vaccine : Group 3 CYD Dengue and JE Vaccine: Group 4
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
Overall Number of Participants Analyzed 25 15 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
3 days Post-Injection 1 Number Analyzed 24 participants 15 participants 22 participants 19 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.3%
5 days Post-Injection 1 Number Analyzed 24 participants 15 participants 21 participants 19 participants
7
  29.2%
5
  33.3%
1
   4.8%
3
  15.8%
7 days Post-Injection 1 Number Analyzed 24 participants 15 participants 20 participants 19 participants
16
  66.7%
9
  60.0%
8
  40.0%
9
  47.4%
14 days Post-Injection 1 Number Analyzed 23 participants 15 participants 18 participants 19 participants
12
  52.2%
4
  26.7%
3
  16.7%
6
  31.6%
3 days Post-Injection 2 Number Analyzed 22 participants 14 participants 16 participants 17 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.9%
5 days Post-Injection 2 Number Analyzed 21 participants 14 participants 17 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7 days Post-Injection 2 Number Analyzed 20 participants 13 participants 17 participants 18 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
14 days Post-Injection 2 Number Analyzed 19 participants 14 participants 16 participants 18 participants
1
   5.3%
1
   7.1%
0
   0.0%
0
   0.0%
3 days Post-Injection 3 Number Analyzed 18 participants 11 participants 15 participants 15 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5 days Post-Injection 3 Number Analyzed 17 participants 12 participants 15 participants 16 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7 days Post-Injection 3 Number Analyzed 18 participants 12 participants 14 participants 16 participants
1
   5.6%
0
   0.0%
0
   0.0%
0
   0.0%
14 days Post-Injection 3 Number Analyzed 18 participants 12 participants 14 participants 16 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Hide Description Viremia was determined by RT PCR using primer/probes specific to each dengue vaccine serotypes.
Time Frame 3, 5, 7 and 14 days post-injection 1; 3 and 14 days post-injection 2 and 7 days post-injection 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on full analysis set. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and JE Vaccine : Group 3 CYD Dengue and JE Vaccine: Group 4
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
Overall Number of Participants Analyzed 25 15 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
Serotype 1: 3 days Post-Injection 1 Number Analyzed 0 participants 0 participants 0 participants 1 participants
0
   0.0%
Serotype 1: 5 days Post-Injection 1 Number Analyzed 7 participants 5 participants 1 participants 3 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Serotype 1: 7 days Post-Injection 1 Number Analyzed 16 participants 9 participants 8 participants 9 participants
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
Serotype 1: 14 days Post-Injection 1 Number Analyzed 12 participants 4 participants 3 participants 6 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Serotype 1: 3 days Post-Injection 2 Number Analyzed 0 participants 0 participants 0 participants 1 participants
0
   0.0%
Serotype 1: 14 days Post-Injection 2 Number Analyzed 1 participants 1 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
Serotype 1: 7 days Post-Injection 3 Number Analyzed 1 participants 0 participants 0 participants 0 participants
0
   0.0%
Serotype 2: 3 days Post-Injection 1 Number Analyzed 0 participants 0 participants 0 participants 1 participants
0
   0.0%
Serotype 2: 5 days Post-Injection 1 Number Analyzed 7 participants 5 participants 1 participants 3 participants
2
  28.6%
0
   0.0%
0
   0.0%
0
   0.0%
Serotype 2: 7 days Post-Injection 1 Number Analyzed 16 participants 9 participants 8 participants 9 participants
2
  12.5%
1
  11.1%
1
  12.5%
0
   0.0%
Serotype 2: 14 days Post-Injection 1 Number Analyzed 12 participants 4 participants 3 participants 6 participants
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
Serotype 2: 3 days Post-Injection 2 Number Analyzed 0 participants 0 participants 0 participants 1 participants
0
   0.0%
Serotype 2: 14 days Post-Injection 2 Number Analyzed 1 participants 1 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
Serotype 2: 7 days Post-Injection 3 Number Analyzed 1 participants 0 participants 0 participants 0 participants
0
   0.0%
Serotype 3: 3 days Post-Injection 1 Number Analyzed 0 participants 0 participants 0 participants 1 participants
0
   0.0%
Serotype 3: 5 days Post-Injection 1 Number Analyzed 7 participants 5 participants 1 participants 3 participants
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
Serotype 3: 7 days Post-Injection 1 Number Analyzed 16 participants 9 participants 8 participants 9 participants
5
  31.3%
2
  22.2%
1
  12.5%
4
  44.4%
Serotype 3: 14 days Post-Injection 1 Number Analyzed 12 participants 4 participants 3 participants 6 participants
1
   8.3%
1
  25.0%
0
   0.0%
1
  16.7%
Serotype 3: 3 days Post-Injection 2 Number Analyzed 0 participants 0 participants 0 participants 1 participants
0
   0.0%
Serotype 3: 14 days Post-Injection 2 Number Analyzed 1 participants 1 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
Serotype 3: 7 days Post-Injection 3 Number Analyzed 1 participants 0 participants 0 participants 0 participants
1
 100.0%
Serotype 4: 3 days Post-Injection 1 Number Analyzed 0 participants 0 participants 0 participants 1 participants
0
   0.0%
Serotype 4: 5 days Post-Injection 1 Number Analyzed 7 participants 5 participants 1 participants 3 participants
6
  85.7%
3
  60.0%
1
 100.0%
2
  66.7%
Serotype 4: 7 days Post-Injection 1 Number Analyzed 16 participants 9 participants 8 participants 9 participants
13
  81.3%
7
  77.8%
5
  62.5%
7
  77.8%
Serotype 4: 14 days Post-Injection 1 Number Analyzed 12 participants 4 participants 3 participants 6 participants
8
  66.7%
2
  50.0%
2
  66.7%
4
  66.7%
Serotype 4: 3 days Post-Injection 2 Number Analyzed 0 participants 0 participants 0 participants 1 participants
0
   0.0%
Serotype 4: 14 days Post-Injection 2 Number Analyzed 1 participants 1 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
Serotype 4: 7 days Post-Injection 3 Number Analyzed 1 participants 0 participants 0 participants 0 participants
0
   0.0%
7.Secondary Outcome
Title Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4
Hide Description GMTs of antibodies against JE were measured by JE micro neutralization assay. The LLOQ of the assay was a titer of 10 (1/dilution).
Time Frame Pre-injection 1, and 28 days post-injection 1, 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on full analysis set. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title CYD Dengue and JE Vaccine : Group 3 CYD Dengue and JE Vaccine: Group 4
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
Overall Number of Participants Analyzed 25 25
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers (1/dilution)
Pre-injection 1 Number Analyzed 25 participants 19 participants
NA [1] 
(NA to NA)
22.9
(12.7 to 41.0)
28 days Post-injection 1 Number Analyzed 19 participants 19 participants
132.3
(48.4 to 361.9)
620.9
(337.5 to 1142.3)
28 days Post-injection 2 Number Analyzed 15 participants 18 participants
382.7
(134.7 to 1087.9)
501.8
(253.0 to 995.5)
28 days Post-injection 3 Number Analyzed 14 participants 16 participants
82.3
(40.3 to 167.9)
157.4
(74.9 to 330.9)
[1]
Participants had a titer reported as < LLOQ.
8.Secondary Outcome
Title Number of Participants With Solicited Injection Site Reactions
Hide Description A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the electronic case report form (eCRF) and considered as related to vaccination. Solicited injection site reactions: pain, erythema, and swelling.
Time Frame Within 7 days after any CYD dengue vaccine and/or JE vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and JE Vaccine : Group 3 CYD Dengue and JE Vaccine: Group 4
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively.
Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
Overall Number of Participants Analyzed 24 15 22 19
Measure Type: Count of Participants
Unit of Measure: Participants
Injection site Pain
7
  29.2%
6
  40.0%
3
  13.6%
6
  31.6%
Injection site Erythema
7
  29.2%
4
  26.7%
2
   9.1%
2
  10.5%
Injection site Swelling
3
  12.5%
2
  13.3%
0
   0.0%
1
   5.3%
9.Secondary Outcome
Title Number of Participants With Solicited Systemic Reactions
Hide Description A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited systemic reactions: fever, headache, malaise, myalgia, and asthenia.
Time Frame Within 14 days after any CYD dengue vaccine and/or JE vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and JE Vaccine : Group 3 CYD Dengue and JE Vaccine: Group 4
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively.
Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively.
Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccines at 0 and 1 months, respectively.
Participants received 2 doses of JE (IXIARO) vaccines at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
Overall Number of Participants Analyzed 24 15 22 19
Measure Type: Count of Participants
Unit of Measure: Participants
Fever
2
   8.3%
2
  13.3%
3
  13.6%
1
   5.3%
Headache
10
  41.7%
11
  73.3%
12
  54.5%
11
  57.9%
Malaise
9
  37.5%
10
  66.7%
11
  50.0%
6
  31.6%
Myalgia
8
  33.3%
6
  40.0%
10
  45.5%
7
  36.8%
Asthenia
6
  25.0%
7
  46.7%
7
  31.8%
3
  15.8%
Time Frame Adverse event (AE) data were collected from Day 0 up to 28 days after each dose of CYD dengue vaccine and/or JE vaccine. Solicited Reaction (SR) data were collected within 7 and 14 days after each and any vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 18 months for Groups 1, 2 and 3 and 19 months for Group 4).
Adverse Event Reporting Description Analysis was performed on Safety Analysis Set. A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
 
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and JE Vaccine : Group 3 CYD Dengue and JE Vaccine: Group 4
Hide Arm/Group Description Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively. Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively. Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively. Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively.
All-Cause Mortality
CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and JE Vaccine : Group 3 CYD Dengue and JE Vaccine: Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/15 (0.00%)      0/25 (0.00%)      0/25 (0.00%)    
Hide Serious Adverse Events
CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and JE Vaccine : Group 3 CYD Dengue and JE Vaccine: Group 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/25 (12.00%)      0/15 (0.00%)      0/25 (0.00%)      1/25 (4.00%)    
Gastrointestinal disorders         
Alcoholic pancreatitis † 1  1/25 (4.00%)  1 0/15 (0.00%)  0 0/25 (0.00%)  0 0/25 (0.00%)  0
Infections and infestations         
Cellulitis † 1  1/25 (4.00%)  1 0/15 (0.00%)  0 0/25 (0.00%)  0 0/25 (0.00%)  0
Injury, poisoning and procedural complications         
Jaw fracture † 1  1/25 (4.00%)  1 0/15 (0.00%)  0 0/25 (0.00%)  0 0/25 (0.00%)  0
Psychiatric disorders         
Drug dependence † 1  0/25 (0.00%)  0 0/15 (0.00%)  0 0/25 (0.00%)  0 1/25 (4.00%)  1
1
Term from vocabulary, MedDRA 16.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and JE Vaccine : Group 3 CYD Dengue and JE Vaccine: Group 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/25 (72.00%)      15/15 (100.00%)      17/25 (68.00%)      20/25 (80.00%)    
Gastrointestinal disorders         
Dental caries † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Diarrhoea † 1  0/25 (0.00%)  0 0/15 (0.00%)  0 1/25 (4.00%)  1 2/25 (8.00%)  4
Enteritis † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Nausea † 1  2/25 (8.00%)  2 1/15 (6.67%)  1 0/25 (0.00%)  0 1/25 (4.00%)  1
Vomiting † 1  3/25 (12.00%)  3 1/15 (6.67%)  1 0/25 (0.00%)  0 2/25 (8.00%)  2
General disorders         
Asthenia † 1  6/25 (24.00%)  12 7/15 (46.67%)  11 7/25 (28.00%)  13 8/25 (32.00%)  14
Fatigue † 1  0/25 (0.00%)  0 2/15 (13.33%)  2 1/25 (4.00%)  1 0/25 (0.00%)  0
Injection site erythema † 1  7/25 (28.00%)  11 4/15 (26.67%)  6 2/25 (8.00%)  2 2/25 (8.00%)  2
Injection site pain † 1  7/25 (28.00%)  8 6/15 (40.00%)  8 8/25 (32.00%)  13 13/25 (52.00%)  25
Injection site pruritus † 1  1/25 (4.00%)  1 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Injection site swelling † 1  3/25 (12.00%)  3 2/15 (13.33%)  3 0/25 (0.00%)  0 1/25 (4.00%)  1
Injection site warmth † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Malaise † 1  9/25 (36.00%)  16 10/15 (66.67%)  12 11/25 (44.00%)  22 11/25 (44.00%)  23
Pyrexia † 1  2/25 (8.00%)  3 2/15 (13.33%)  2 3/25 (12.00%)  3 2/25 (8.00%)  3
Immune system disorders         
Seasonal allergy † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Infections and infestations         
Bronchitis † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Gastroenteritis † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 1/25 (4.00%)  1 1/25 (4.00%)  1
Gastroenteritis viral † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 1/25 (4.00%)  1
Influenza † 1  0/25 (0.00%)  0 0/15 (0.00%)  0 0/25 (0.00%)  0 2/25 (8.00%)  2
Lice infestation † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Nasopharyngitis † 1  4/25 (16.00%)  7 2/15 (13.33%)  3 2/25 (8.00%)  2 6/25 (24.00%)  7
Oral infection † 1  1/25 (4.00%)  1 0/15 (0.00%)  0 2/25 (8.00%)  2 0/25 (0.00%)  0
Sinusitis † 1  2/25 (8.00%)  2 1/15 (6.67%)  1 0/25 (0.00%)  0 3/25 (12.00%)  3
Trichomoniasis † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Upper respiratory tract infection † 1  7/25 (28.00%)  7 7/15 (46.67%)  7 3/25 (12.00%)  3 7/25 (28.00%)  7
Urinary tract infection † 1  1/25 (4.00%)  1 3/15 (20.00%)  5 0/25 (0.00%)  0 0/25 (0.00%)  0
Vaginal infection † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Injury, poisoning and procedural complications         
Contusion † 1  0/25 (0.00%)  0 0/15 (0.00%)  0 2/25 (8.00%)  2 1/25 (4.00%)  3
Foot fracture † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 1/25 (4.00%)  1
Ligament sprain † 1  1/25 (4.00%)  1 1/15 (6.67%)  1 1/25 (4.00%)  1 0/25 (0.00%)  0
Investigations         
Heart rate decreased † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 1/25 (4.00%)  1
Heart rate increased † 1  3/25 (12.00%)  3 1/15 (6.67%)  1 1/25 (4.00%)  1 2/25 (8.00%)  2
Hepatic enzyme increased † 1  0/25 (0.00%)  0 1/15 (6.67%)  2 0/25 (0.00%)  0 0/25 (0.00%)  0
Metabolism and nutrition disorders         
Vitamin D deficiency † 1  1/25 (4.00%)  1 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Back pain † 1  1/25 (4.00%)  1 1/15 (6.67%)  1 2/25 (8.00%)  2 3/25 (12.00%)  3
Bunion † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Bursitis † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Enostosis † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Myalgia † 1  9/25 (36.00%)  14 6/15 (40.00%)  11 10/25 (40.00%)  22 10/25 (40.00%)  22
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Haemangioma of liver † 1  1/25 (4.00%)  1 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Nervous system disorders         
Disturbance in attention † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Headache † 1  9/25 (36.00%)  27 13/15 (86.67%)  22 12/25 (48.00%)  37 14/25 (56.00%)  46
Migraine † 1  2/25 (8.00%)  5 0/15 (0.00%)  0 1/25 (4.00%)  1 0/25 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Vomiting in pregnancy † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Psychiatric disorders         
Attention deficit/hyperactivity disorder † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Insomnia † 1  2/25 (8.00%)  3 2/15 (13.33%)  2 0/25 (0.00%)  0 1/25 (4.00%)  1
Post-traumatic stress disorder † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Sleep disorder † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Renal and urinary disorders         
Renal cyst † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Reproductive system and breast disorders         
Breast tenderness † 1  0/25 (0.00%)  0 1/15 (6.67%)  2 0/25 (0.00%)  0 0/25 (0.00%)  0
Dysmenorrhoea † 1  1/25 (4.00%)  1 2/15 (13.33%)  2 3/25 (12.00%)  3 3/25 (12.00%)  7
Respiratory, thoracic and mediastinal disorders         
Cough † 1  2/25 (8.00%)  2 0/15 (0.00%)  0 1/25 (4.00%)  2 0/25 (0.00%)  0
Oropharyngeal pain † 1  2/25 (8.00%)  2 1/15 (6.67%)  1 2/25 (8.00%)  2 2/25 (8.00%)  2
Pleuritic pain † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Sinus congestion † 1  0/25 (0.00%)  0 2/15 (13.33%)  2 2/25 (8.00%)  3 2/25 (8.00%)  2
Skin and subcutaneous tissue disorders         
Acne † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Rash † 1  0/25 (0.00%)  0 0/15 (0.00%)  0 1/25 (4.00%)  1 2/25 (8.00%)  5
Rash papular † 1  0/25 (0.00%)  0 1/15 (6.67%)  2 0/25 (0.00%)  0 0/25 (0.00%)  0
Vascular disorders         
Hypertension † 1  2/25 (8.00%)  2 0/15 (0.00%)  0 1/25 (4.00%)  1 0/25 (0.00%)  0
Hypotension † 1  0/25 (0.00%)  0 1/15 (6.67%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
1
Term from vocabulary, MedDRA 16.1
†
Indicates events were collected by systematic assessment
[Not Specified]
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 Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi Pasteur
Phone: 800-633-1610 ext 1#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01943825    
Other Study ID Numbers: CYD56
U1111-1143-8391 ( Other Identifier: WHO )
First Submitted: September 12, 2013
First Posted: September 17, 2013
Results First Submitted: December 19, 2019
Results First Posted: February 5, 2020
Last Update Posted: February 5, 2020