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Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Given With or Without Yellow Fever Vaccine

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ClinicalTrials.gov Identifier: NCT01488890
Recruitment Status : Completed
First Posted : December 8, 2011
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
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
Yellow Fever
Interventions Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus
Biological: Yellow Fever
Enrollment 390
Recruitment Details Study participants were enrolled from 06 December 2011 to 22 March 2012 in the United States.
Pre-assignment Details A total of 390 participants were enrolled and randomized in the study.
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and Yellow Fever (YF) Vaccine: Group 3 Yellow Fever Vaccine: Group 4
Hide Arm/Group Description Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. Participants received single dose of YF vaccine at Day 0.
Period Title: Overall Study
Started 120 120 120 30
Treated 120 120 119 30
Completed 88 100 85 25
Not Completed 32 20 35 5
Reason Not Completed
Serious adverse event             2             0             0             0
Protocol Violation             3             0             4             0
Lost to Follow-up             13             10             20             3
Withdrawal by Subject             14             10             11             2
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and Yellow Fever Vaccine: Group 3 Yellow Fever Vaccine: Group 4 Total
Hide Arm/Group Description Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. Participants received single dose of YF vaccine at Day 0. Total of all reporting groups
Overall Number of Baseline Participants 120 120 120 30 390
Hide Baseline Analysis Population Description
Analysis was performed on all randomized participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 120 participants 120 participants 30 participants 390 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
120
 100.0%
120
 100.0%
120
 100.0%
30
 100.0%
390
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 120 participants 120 participants 30 participants 390 participants
31.6  (7.63) 32.6  (7.32) 32.6  (7.52) 34.8  (8.63) 32.5  (7.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 120 participants 120 participants 30 participants 390 participants
Female
57
  47.5%
61
  50.8%
60
  50.0%
17
  56.7%
195
  50.0%
Male
63
  52.5%
59
  49.2%
60
  50.0%
13
  43.3%
195
  50.0%
1.Primary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Hide Description GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test (PRNT).
Time Frame Pre-injection 1, 28 days and 6 months post-injection 3
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included participants who received at least 1 Inj. of CYD dengue or/ YF vaccine, had at least 1 blood sample drawn and valid post-Inj. serology result. Here, ‘Number analyzed’ = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 3 and 4.
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
Overall Number of Participants Analyzed 117 119
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Dengue Virus Serotype 1: Pre-injection 1 Number Analyzed 117 participants 119 participants
5.38
(4.85 to 5.96)
5.13
(4.98 to 5.28)
Dengue Virus Serotype 1: 28 days Post-injection 3 Number Analyzed 93 participants 108 participants
14.8
(11.3 to 19.4)
15.9
(12.6 to 20.0)
Dengue Virus Serotype 1: 6 months Post-injection 3 Number Analyzed 88 participants 104 participants
13.3
(10.2 to 17.4)
9.01
(7.54 to 10.8)
Dengue Virus Serotype 2: Pre-injection 1 Number Analyzed 117 participants 119 participants
5.19
(4.82 to 5.58)
5.22
(4.96 to 5.50)
Dengue Virus Serotype 2: 28 days Post-injection 3 Number Analyzed 94 participants 108 participants
51.2
(38.2 to 68.6)
59.9
(45.8 to 78.4)
Dengue Virus Serotype 2: 6 months Post-injection 3 Number Analyzed 88 participants 104 participants
45.6
(31.6 to 65.6)
38.7
(29.5 to 50.8)
Dengue Virus Serotype 3: Pre-injection Number Analyzed 117 participants 119 participants
5.32
(4.94 to 5.73)
5.28
(5.03 to 5.55)
Dengue Virus Serotype 3: 28 days Post-injection 3 Number Analyzed 94 participants 107 participants
45.7
(35.0 to 59.8)
59.3
(47.0 to 74.7)
Dengue Virus Serotype 3: 6 months Post-injection 3 Number Analyzed 88 participants 104 participants
30.2
(22.8 to 40.2)
34.5
(27.5 to 43.3)
Dengue Virus Serotype 4: Pre-injection 1 Number Analyzed 117 participants 119 participants
5.78
(5.16 to 6.48)
5.11
(4.90 to 5.33)
Dengue Virus Serotype 4: Post-injection 3 Number Analyzed 94 participants 107 participants
66.8
(50.9 to 87.8)
83.1
(61.4 to 112)
Dengue Virus Serotype 4: 6 months Post-injection 3 Number Analyzed 88 participants 104 participants
74.8
(54.9 to 102)
41.7
(31.2 to 55.9)
2.Primary Outcome
Title Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2
Hide Description Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution).
Time Frame Pre-injection 1, 28 days 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. Data for this outcome measure was not planned to be collected, analyzed for Group 3 and 4.
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
Overall Number of Participants Analyzed 117 119
Measure Type: Number
Unit of Measure: percentage of participants
Dengue Virus Serotype 1: Pre-injection 1 Number Analyzed 117 participants 119 participants
1.7 2.5
Dengue Virus Serotype 1: 28 days Post-injection 3 Number Analyzed 93 participants 108 participants
52.7 56.5
Dengue Virus Serotype 1: 6 months Post-injection 3 Number Analyzed 88 participants 104 participants
47.7 32.7
Dengue Virus Serotype 2: Pre-injection 1 Number Analyzed 117 participants 119 participants
0.9 2.5
Dengue Virus Serotype 2: 28 days Post-injection 3 Number Analyzed 94 participants 108 participants
84.0 88.0
Dengue Virus Serotype 2: 6 months Post-injection 3 Number Analyzed 88 participants 104 participants
75.0 80.8
Dengue Virus Serotype 3: Pre-injection 1 Number Analyzed 117 participants 119 participants
2.6 4.2
Dengue Virus Serotype 3: 28 days Post-injection 3 Number Analyzed 94 participants 107 participants
85.1 90.7
Dengue Virus Serotype 3: 6 months Post-injection 3 Number Analyzed 88 participants 104 participants
79.5 80.8
Dengue Virus Serotype 4: Pre-injection 1 Number Analyzed 117 participants 119 participants
6.8 0.8
Dengue Virus Serotype 4: 28 days Post-injection 3 Number Analyzed 94 participants 107 participants
88.3 86.0
Dengue Virus Serotype 4: 6 months Post-injection 3 Number Analyzed 88 participants 104 participants
86.4 74.0
3.Secondary Outcome
Title Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Hide Description GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT.
Time Frame Pre-injection 1 and 2 and 28 days post-injection 1 and 2
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 for this outcome measure was not planned to be collected and analyzed for Group 3 and 4.
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
Overall Number of Participants Analyzed 117 119
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer (1/dilution)
Dengue Virus Serotype 1: Pre-injection 1 Number Analyzed 117 participants 119 participants
5.38
(4.85 to 5.96)
5.13
(4.98 to 5.28)
Dengue Virus Serotype 1: 28 days Post-injection 1 Number Analyzed 117 participants 118 participants
10.3
(8.15 to 13.1)
8.75
(7.19 to 10.6)
Dengue Virus Serotype 1: Pre-injection 2 Number Analyzed 107 participants 118 participants
11.2
(8.76 to 14.4)
11.5
(9.17 to 14.4)
Dengue Virus Serotype 1: 28 days Post-injection 2 Number Analyzed 101 participants 116 participants
18.9
(14.3 to 25.1)
14.9
(11.9 to 18.6)
Dengue Virus Serotype 2: Pre-injection 1 Number Analyzed 117 participants 119 participants
5.19
(4.82 to 5.58)
5.22
(4.96 to 5.50)
Dengue Virus Serotype 2: 28 days Post-injection 1 Number Analyzed 117 participants 119 participants
30.9
(22.9 to 41.8)
24.2
(18.0 to 32.4)
Dengue Virus Serotype 2: Pre-injection 2 Number Analyzed 106 participants 118 participants
38.4
(26.2 to 56.1)
40.0
(28.9 to 55.3)
Dengue Virus Serotype 2: 28 days Post-injection 2 Number Analyzed 101 participants 116 participants
64.1
(47.3 to 86.9)
66.9
(50.9 to 87.9)
Dengue Virus Serotype 3: Pre-injection 1 Number Analyzed 117 participants 119 participants
5.32
(4.94 to 5.73)
5.28
(5.03 to 5.55)
Dengue Virus Serotype 3: 28 days Post-injection 1 Number Analyzed 117 participants 117 participants
32.5
(23.8 to 44.4)
31.0
(22.9 to 41.8)
Dengue Virus Serotype 3: Pre-injection 2 Number Analyzed 107 participants 118 participants
26.2
(19.3 to 35.5)
34.5
(25.3 to 47.1)
Dengue Virus Serotype 3: 28 days Post-injection 2 Number Analyzed 101 participants 116 participants
47.9
(36.1 to 63.5)
62.0
(46.8 to 82.2)
Dengue Virus Serotype 4: Pre-injection 1 Number Analyzed 117 participants 119 participants
5.78
(5.16 to 6.48)
5.11
(4.90 to 5.33)
Dengue Virus Serotype 4: 28 days Post-injection 1 Number Analyzed 115 participants 117 participants
121
(74.2 to 197)
126
(77.5 to 204)
Dengue Virus Serotype 4: Pre-injection 2 Number Analyzed 106 participants 117 participants
60.2
(42.2 to 85.8)
89.8
(58.6 to 138)
Dengue Virus Serotype 4: 28 days Post-injection 2 Number Analyzed 101 participants 113 participants
104
(75.0 to 144)
111
(78.1 to 159)
4.Secondary Outcome
Title Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2
Hide Description Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution).
Time Frame Pre-injection 1 and 2 and 28 days post-injection 1 and 2
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 for this outcome measure was not planned to be collected and analyzed for Group 3 and 4.
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
Overall Number of Participants Analyzed 117 119
Measure Type: Number
Unit of Measure: Percentage of participants
Dengue Virus Serotype 1: Pre-injection 1 Number Analyzed 117 participants 119 participants
1.7 2.5
Dengue Virus Serotype 1: 28 days Post-injection 1 Number Analyzed 117 participants 118 participants
34.2 24.6
Dengue Virus Serotype 1: Pre-injection 2 Number Analyzed 107 participants 118 participants
35.5 35.6
Dengue Virus Serotype 1: 28 days Post-injection 2 Number Analyzed 101 participants 116 participants
58.4 52.6
Dengue Virus Serotype 2: Pre-injection 1 Number Analyzed 117 participants 119 participants
0.9 2.5
Dengue Virus Serotype 2: 28 days Post-injection 1 Number Analyzed 117 participants 119 participants
65.0 56.3
Dengue Virus Serotype 2: Pre-injection 2 Number Analyzed 106 participants 118 participants
61.3 68.6
Dengue Virus Serotype 2: 28 days Post-injection 2 Number Analyzed 101 participants 116 participants
86.1 87.9
Dengue Virus Serotype 3: Pre-injection 1 Number Analyzed 117 participants 119 participants
2.6 4.2
Dengue Virus Serotype 3: 28 days Post-injection 1 Number Analyzed 117 participants 117 participants
63.2 64.1
Dengue Virus Serotype 3: Pre-injection 2 Number Analyzed 107 participants 118 participants
61.7 66.1
Dengue Virus Serotype 3: 28 days Post-injection 2 Number Analyzed 101 participants 116 participants
80.2 84.5
Dengue Virus Serotype 4: Pre-injection 1 Number Analyzed 117 participants 119 participants
6.8 0.8
Dengue Virus Serotype 4: 28 days Post-injection 1 Number Analyzed 115 participants 117 participants
67.8 67.5
Dengue Virus Serotype 4: Pre-injection 2 Number Analyzed 106 participants 117 participants
71.7 67.5
Dengue Virus Serotype 4: 28 days Post-injection 2 Number Analyzed 101 participants 113 participants
84.2 80.5
5.Secondary Outcome
Title Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 In YF Non-Immune Participants: Group 1 and Group 2 (Pooled) and Group 3
Hide Description GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test-50 (PRNT50). Groups 1 and 2 data was reported as pooled data. YF-non immune participants were defined as participants with YF baseline titer PRNT80 < 10 (1/dilution).
Time Frame Pre-injection 1 and 28 days post-injection 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full Analysis Set. Here, “Overall number of participants analyzed = participants evaluable for this outcome measure” and ‘Number analyzed’ = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 4.
Arm/Group Title CYD Dengue Vaccine Group 1 and 2: Pooled CYD Dengue and Yellow Fever Vaccine: Group 3
Hide Arm/Group Description:
All Participants who received 3 doses of CYD dengue vaccine in Group 1 and 2.
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
Overall Number of Participants Analyzed 116 108
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer (1/dilution)
Dengue Virus Serotype 1: Pre-injection 1 Number Analyzed 116 participants 108 participants
5.19
(4.87 to 5.53)
5.00 [1] 
(NA to NA)
Dengue Virus Serotype 1: 28 days Post-injection 1 Number Analyzed 116 participants 108 participants
8.71
(7.04 to 10.8)
7.68
(6.46 to 9.14)
Dengue Virus Serotype 2: Pre-injection 1 Number Analyzed 116 participants 108 participants
5.06
(4.94 to 5.19)
5.06
(4.94 to 5.20)
Dengue Virus Serotype 2: 28 days Post-injection 1 Number Analyzed 116 participants 108 participants
18.8
(13.9 to 25.3)
10.8
(8.63 to 13.4)
Dengue Virus Serotype 3: Pre-injection 1 Number Analyzed 116 participants 108 participants
5.21
(4.97 to 5.47)
5.28
(4.90 to 5.69)
Dengue Virus Serotype 3: 28 days Post-injection 1 Number Analyzed 114 participants 108 participants
28.5
(20.4 to 39.7)
8.88
(7.23 to 10.9)
Dengue Virus Serotype 4: Pre-injection 1 Number Analyzed 116 participants 108 participants
5.43
(4.99 to 5.92)
5.26
(4.90 to 5.65)
Dengue Virus Serotype 4: 28 days Post-injection 1 Number Analyzed 114 participants 107 participants
229
(139 to 378)
22.6
(15.9 to 32.3)
[1]
The confidence interval (CI) of Geometric Mean was not calculated when standard deviation (SD) = 0.
6.Secondary Outcome
Title Percentage of YF Non-Immune Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1: Group 1 and Group 2 (Pooled) and Group 3
Hide Description Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). Groups 1 and 2 data was reported as pooled data. YF-non immune participants were defined as participants with YF baseline titer dengue plaque reduction neutralization test-80 (PRNT80) <10 (1/dilution).
Time Frame Pre-injection 1 and 28 days post-injection 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full Analysis Set. Here, “Overall number of participants analyzed = participants evaluable for this outcome measure” and ‘Number analyzed’ = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 4.
Arm/Group Title CYD Dengue Vaccine Group 1 and Group 2: Pooled CYD Dengue and Yellow Fever Vaccine: Group 3
Hide Arm/Group Description:
All participants who received 3 doses of CYD dengue vaccine in Group 1 and Group 2.
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
Overall Number of Participants Analyzed 116 108
Measure Type: Number
Unit of Measure: percentage of participants
Dengue Virus Serotype 1: Pre-injection 1 Number Analyzed 116 participants 108 participants
1.7 0.0
Dengue Virus Serotype 1: 28 days Post-injection 1 Number Analyzed 116 participants 108 participants
23.3 20.4
Dengue Virus Serotype 2: Pre-injection 1 Number Analyzed 116 participants 108 participants
0.9 0.9
Dengue Virus Serotype 2: 28 days Post-injection 1 Number Analyzed 116 participants 108 participants
46.6 35.2
Dengue Virus Serotype 3: Pre-injection 1 Number Analyzed 116 participants 108 participants
2.6 2.8
Dengue Virus Serotype 3: 28 days Post-injection 1 Number Analyzed 114 participants 108 participants
57.9 25.0
Dengue Virus Serotype 4: Pre-injection 1 Number Analyzed 116 participants 108 participants
3.4 1.9
Dengue Virus Serotype 4: 28 days Post-injection 1 Number Analyzed 114 participants 107 participants
74.6 48.6
7.Secondary Outcome
Title Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Hide Description GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. FV immune participants were defined as participants with titer >= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer >= 10 (1/dilution) for YF virus (sera with PRNT80 result).
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, Here, ‘Overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘Number analyzed’ = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and Yellow Fever Vaccine: Group 3
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
Overall Number of Participants Analyzed 63 65 11
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer (1/dilution)
Dengue Virus Serotype 1: Pre-injection 1 Number Analyzed 63 participants 65 participants 11 participants
5.73
(4.72 to 6.94)
5.23
(4.96 to 5.53)
14.3
(2.79 to 73.0)
Dengue Virus Serotype 1: 28 days Post-injection 1 Number Analyzed 63 participants 64 participants 11 participants
13.9
(9.46 to 20.3)
9.25
(6.96 to 12.3)
27.2
(5.96 to 124)
Dengue Virus Serotype 1: Pre-injection 2 Number Analyzed 56 participants 65 participants 11 participants
18.0
(11.9 to 27.1)
12.8
(9.22 to 17.8)
36.1
(5.89 to 221)
Dengue Virus Serotype 1: 28 days Post-injection 2 Number Analyzed 53 participants 63 participants 10 participants
25.0
(16.6 to 37.8)
16.7
(12.6 to 22.2)
31.4
(8.55 to 115)
Dengue Virus Serotype 1: Pre-injection 3 Number Analyzed 51 participants 58 participants 9 participants
12.7
(8.67 to 18.6)
10.6
(7.98 to 14.1)
36.3
(5.08 to 260)
Dengue Virus Serotype 1: 28 days Post-injection 3 Number Analyzed 51 participants 59 participants 9 participants
15.6
(10.6 to 23.0)
17.2
(12.7 to 23.3)
79.0
(17.2 to 362)
Dengue Virus Serotype 2: Pre-injection 1 Number Analyzed 63 participants 65 participants 11 participants
5.35
(4.67 to 6.13)
5.42
(4.93 to 5.96)
13.5
(3.71 to 49.4)
Dengue Virus Serotype 2: 28 days Post-injection 1 Number Analyzed 63 participants 65 participants 11 participants
48.1
(32.8 to 70.5)
34.4
(23.0 to 51.4)
66.3
(18.9 to 233)
Dengue Virus Serotype 2: Pre-injection 2 Number Analyzed 56 participants 65 participants 11 participants
72.3
(42.3 to 123)
45.0
(29.8 to 67.9)
70.2
(18.1 to 272)
Dengue Virus Serotype 2: 28 days Post-injection 2 Number Analyzed 53 participants 63 participants 10 participants
83.7
(54.6 to 128)
74.6
(54.5 to 102)
122
(38.4 to 386)
Dengue Virus Serotype 2: Pre-injection 3 Number Analyzed 51 participants 60 participants 9 participants
43.0
(25.9 to 71.3)
62.3
(42.1 to 92.1)
63.6
(18.7 to 217)
Dengue Virus Serotype 2: 28 days Post-injection 3 Number Analyzed 52 participants 59 participants 9 participants
60.0
(39.4 to 91.4)
68.1
(48.9 to 94.7)
133
(56.8 to 313)
Dengue Virus Serotype 3: Pre-injection 1 Number Analyzed 63 participants 65 participants 11 participants
5.61
(4.89 to 6.45)
5.53
(5.06 to 6.05)
21.5
(6.05 to 76.2)
Dengue Virus Serotype 3: 28 days Post-injection 1 Number Analyzed 63 participants 65 participants 11 participants
45.1
(30.5 to 66.8)
31.2
(21.2 to 46.1)
98.0
(51.6 to 186)
Dengue Virus Serotype 3: Pre-injection 2 Number Analyzed 56 participants 65 participants 11 participants
47.8
(33.0 to 69.2)
41.1
(27.1 to 62.4)
105
(27.7 to 396)
Dengue Virus Serotype 3: 28 days Post-injection 2 Number Analyzed 53 participants 63 participants 10 participants
72.5
(51.6 to 102)
69.6
(49.9 to 97.0)
158
(64.1 to 391)
Dengue Virus Serotype 3: Pre-injection 3 Number Analyzed 51 participants 60 participants 9 participants
29.9
(20.4 to 43.7)
48.3
(33.9 to 68.7)
106
(21.7 to 516)
Dengue Virus Serotype 3: 28 days Post-injection 3 Number Analyzed 52 participants 59 participants 9 participants
44.8
(31.3 to 64.3)
71.2
(53.4 to 94.8)
130
(36.3 to 463)
Dengue Virus Serotype 4: Pre-injection 1 Number Analyzed 63 participants 65 participants 11 participants
6.55
(5.32 to 8.07)
5.20
(4.81 to 5.63)
15.6
(5.33 to 45.6)
Dengue Virus Serotype 4: 28 days Post-injection 1 Number Analyzed 61 participants 65 participants 11 participants
78.2
(42.4 to 144)
77.9
(42.1 to 144)
215
(49.9 to 924)
Dengue Virus Serotype 4: Pre-injection 2 Number Analyzed 56 participants 65 participants 11 participants
65.9
(40.8 to 107)
65.0
(37.9 to 111)
235
(52.1 to 1059)
Dengue Virus Serotype 4: 28 days Post-injection 2 Number Analyzed 53 participants 61 participants 10 participants
89.6
(55.9 to 144)
88.8
(56.0 to 141)
223
(65.3 to 763)
Dengue Virus Serotype 4: Pre-injection 3 Number Analyzed 51 participants 60 participants 9 participants
40.0
(25.9 to 61.6)
68.3
(45.0 to 104)
146
(40.0 to 531)
Dengue Virus Serotype 4: 28 days Post-injection 3 Number Analyzed 52 participants 59 participants 9 participants
51.7
(35.1 to 76.2)
78.5
(54.3 to 114)
182
(103 to 319)
8.Secondary Outcome
Title Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Hide Description GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. FV non-immune participants were defined as participants with titer < 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer <10 (1/dilution) for YF virus (using sera with PRNT80 result).
Time Frame Pre-injection 1, 2, 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, Here, ‘Overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘Number analyzed’ = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 4.
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and Yellow Fever Vaccine: Group 3
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
Overall Number of Participants Analyzed 54 54 103
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer (1/dilution)
Dengue Virus Serotype 1: Pre-injection 1 Number Analyzed 54 participants 54 participants 103 participants
5.00 [1] 
(NA to NA)
5.00 [1] 
(NA to NA)
5.00 [1] 
(NA to NA)
Dengue Virus Serotype 1: 28 days Post-injection 1 Number Analyzed 54 participants 54 participants 103 participants
7.31
(5.79 to 9.23)
8.18
(6.22 to 10.8)
7.50
(6.30 to 8.92)
Dengue Virus Serotype 1: Pre-injection 2 Number Analyzed 51 participants 53 participants 100 participants
6.73
(5.49 to 8.23)
10.1
(7.40 to 13.7)
7.76
(6.46 to 9.32)
Dengue Virus Serotype 1: 28 days Post-injection 2 Number Analyzed 48 participants 53 participants 90 participants
13.9
(9.64 to 20.2)
13.0
(9.12 to 18.5)
10.9
(8.55 to 14.0)
Dengue Virus Serotype 1: Pre-injection 3 Number Analyzed 47 participants 50 participants 84 participants
6.71
(5.54 to 8.13)
8.97
(6.70 to 12.0)
10.8
(8.52 to 13.8)
Dengue Virus Serotype 1: 28 days Post-injection 3 Number Analyzed 42 participants 49 participants 84 participants
13.9
(9.49 to 20.4)
14.4
(10.1 to 20.7)
18.5
(13.9 to 24.8)
Dengue Virus Serotype 2: Pre-injection 1 Number Analyzed 54 participants 54 participants 103 participants
5.00 [1] 
(NA to NA)
5.00 [1] 
(NA to NA)
5.00 [1] 
(NA to NA)
Dengue Virus Serotype 2: 28 days Post-injection 1 Number Analyzed 54 participants 54 participants 103 participants
18.5
(11.8 to 28.9)
15.8
(10.4 to 23.9)
10.3
(8.26 to 13.0)
Dengue Virus Serotype 2: Pre-injection 2 Number Analyzed 50 participants 53 participants 100 participants
18.9
(11.6 to 30.7)
34.6
(20.4 to 58.6)
11.6
(8.87 to 15.1)
Dengue Virus Serotype 2: 28 days Post-injection 2 Number Analyzed 48 participants 53 participants 90 participants
47.8
(31.0 to 73.7)
58.8
(36.5 to 94.8)
30.8
(22.3 to 42.6)
Dengue Virus Serotype 2: Pre-injection 3 Number Analyzed 47 participants 51 participants 86 participants
18.2
(12.0 to 27.7)
32.4
(21.5 to 48.9)
23.1
(16.3 to 32.9)
Dengue Virus Serotype 2: 28 days Post-injection 3 Number Analyzed 42 participants 49 participants 84 participants
42.1
(27.9 to 63.4)
51.4
(32.8 to 80.6)
46.4
(33.8 to 63.6)
Dengue Virus Serotype 3: Pre-injection 1 Number Analyzed 54 participants 54 participants 103 participants
5.00 [1] 
(NA to NA)
5.00 [1] 
(NA to NA)
5.00 [1] 
(NA to NA)
Dengue Virus Serotype 3: 28 days Post-injection 1 Number Analyzed 54 participants 52 participants 103 participants
22.2
(13.6 to 36.2)
30.7
(18.8 to 49.9)
8.00
(6.60 to 9.71)
Dengue Virus Serotype 3: Pre-injection 2 Number Analyzed 51 participants 53 participants 100 participants
13.5
(8.76 to 20.8)
27.8
(17.3 to 44.8)
9.06
(7.18 to 11.4)
Dengue Virus Serotype 3: 28 days Post-injection 2 Number Analyzed 48 participants 53 participants 90 participants
30.3
(19.5 to 46.8)
54.1
(33.3 to 87.8)
18.5
(13.6 to 25.2)
Dengue Virus Serotype 3: Pre-injection 3 Number Analyzed 47 participants 50 participants 86 participants
19.8
(13.5 to 29.1)
27.2
(18.3 to 40.3)
17.5
(12.9 to 23.6)
Dengue Virus Serotype 3: 28 days Post-injection 3 Number Analyzed 42 participants 48 participants 83 participants
46.9
(30.9 to 71.2)
47.3
(32.5 to 69.0)
30.2
(22.8 to 40.1)
Dengue Virus Serotype 4: Pre-injection 1 Number Analyzed 54 participants 54 participants 103 participants
5.00 [1] 
(NA to NA)
5.00 [1] 
(NA to NA)
5.00 [1] 
(NA to NA)
Dengue Virus Serotype 4: 28 days Post-injection 1 Number Analyzed 54 participants 52 participants 102 participants
197
(90.9 to 428)
229
(107 to 488)
20.5
(14.3 to 29.4)
Dengue Virus Serotype 4: Pre-injection 2 Number Analyzed 50 participants 52 participants 100 participants
54.4
(31.6 to 93.5)
135
(67.5 to 268)
18.2
(12.6 to 26.3)
Dengue Virus Serotype 4: 28 days Post-injection 2 Number Analyzed 48 participants 52 participants 90 participants
122
(77.3 to 193)
145
(83.0 to 253)
42.8
(29.2 to 62.7)
Dengue Virus Serotype 4: Pre-injection 3 Number Analyzed 47 participants 49 participants 85 participants
62.8
(39.2 to 101)
82.9
(48.2 to 143)
47.8
(34.2 to 66.7)
Dengue Virus Serotype 4: 28 days Post-injection 3 Number Analyzed 42 participants 48 participants 83 participants
91.8
(63.3 to 133)
89.2
(53.3 to 149)
71.2
(52.0 to 97.7)
[1]
The CI of Geometric Mean was not calculated when SD = 0.
9.Secondary Outcome
Title Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)
Hide Description Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). FV immune participants at baseline were defined as participants with titer >= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer >=10 (1/dilution) for YF virus (sera with PRNT80 result).
Time Frame Pre-injection 1, 2, 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, Here, ‘Overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘Number analyzed’ = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and Yellow Fever Vaccine: Group 3
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
Overall Number of Participants Analyzed 63 65 11
Measure Type: Number
Unit of Measure: percentage of participants
Dengue Virus Serotype 1: Pre-injection 1 Number Analyzed 63 participants 65 participants 11 participants
3.2 4.6 18.2
Dengue Virus Serotype 1: 28 days Post-injection 1 Number Analyzed 63 participants 64 participants 11 participants
47.6 26.6 45.5
Dengue Virus Serotype 1: Pre-injection 2 Number Analyzed 56 participants 65 participants 11 participants
51.8 38.5 54.5
Dengue Virus Serotype 1: 28 days Post-injection 2 Number Analyzed 53 participants 63 participants 10 participants
67.9 61.9 70.0
Dengue Virus Serotype 1: Pre-injection 3 Number Analyzed 51 participants 58 participants 9 participants
45.1 36.2 55.6
Dengue Virus Serotype 1: 28 days Post-injection 3 Number Analyzed 51 participants 59 participants 9 participants
54.9 61.0 88.9
Dengue Virus Serotype 2: Pre-injection 1 Number Analyzed 63 participants 65 participants 11 participants
1.6 4.6 27.3
Dengue Virus Serotype 2: 28 days Post-injection 1 Number Analyzed 63 participants 65 participants 11 participants
79.4 69.2 81.8
Dengue Virus Serotype 2: Pre-injection 2 Number Analyzed 56 participants 65 participants 11 participants
75.0 75.4 72.7
Dengue Virus Serotype 2: 28 days Post-injection 2 Number Analyzed 53 participants 63 participants 10 participants
88.7 95.2 100.0
Dengue Virus Serotype 2: Pre-injection 3 Number Analyzed 51 participants 60 participants 9 participants
70.6 86.7 88.9
Dengue Virus Serotype 2: 28 days Post-injection 3 Number Analyzed 52 participants 59 participants 9 participants
84.6 94.9 100.0
Dengue Virus Serotype 3: Pre-injection 1 Number Analyzed 63 participants 65 participants 11 participants
4.8 7.7 54.5
Dengue Virus Serotype 3: 28 days Post-injection 1 Number Analyzed 63 participants 65 participants 11 participants
74.6 66.2 100.0
Dengue Virus Serotype 3: Pre-injection 2 Number Analyzed 56 participants 65 participants 11 participants
80.4 70.8 81.8
Dengue Virus Serotype 3: 28 days Post-injection 2 Number Analyzed 53 participants 63 participants 10 participants
90.6 92.1 100.0
Dengue Virus Serotype 3: Pre-injection 3 Number Analyzed 51 participants 60 participants 9 participants
74.5 85.0 77.8
Dengue Virus Serotype 3: 28 days Post-injection 3 Number Analyzed 52 participants 59 participants 9 participants
84.6 94.9 88.9
Dengue Virus Serotype 4: Pre-injection 1 Number Analyzed 63 participants 65 participants 11 participants
12.7 1.5 36.4
Dengue Virus Serotype 4: 28 days Post-injection 1 Number Analyzed 61 participants 65 participants 11 participants
65.6 61.5 90.9
Dengue Virus Serotype 4: Pre-injection 2 Number Analyzed 56 participants 65 participants 11 participants
76.8 63.1 90.9
Dengue Virus Serotype 4: 28 days Post-injection 2 Number Analyzed 53 participants 61 participants 10 participants
81.1 78.7 100.0
Dengue Virus Serotype 4: Pre-injection 3 Number Analyzed 51 participants 60 participants 9 participants
74.5 76.7 88.9
Dengue Virus Serotype 4: 28 days Post-injection 3 Number Analyzed 52 participants 59 participants 9 participants
82.7 88.1 100.0
10.Secondary Outcome
Title Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)
Hide Description Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). FV non-immune participants were defined as participants with titer < 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer <10 (1/dilution) for YF virus (using sera with PRNT80 result).
Time Frame Pre injection 1, 2, 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, ‘Overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘Number analyzed’ = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 4.
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and Yellow Fever Vaccine: Group 3
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months.
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
Overall Number of Participants Analyzed 54 54 103
Measure Type: Number
Unit of Measure: percentage of participants
Dengue Virus Serotype 1: Pre-injection 1 Number Analyzed 54 participants 54 participants 103 participants
0.0 0.0 0.0
Dengue Virus Serotype 1: 28 days Post-injection 1 Number Analyzed 54 participants 54 participants 103 participants
18.5 22.2 19.4
Dengue Virus Serotype 1: Pre-injection 2 Number Analyzed 51 participants 53 participants 100 participants
17.6 32.1 22.0
Dengue Virus Serotype 1: 28 days Post-injection 2 Number Analyzed 48 participants 53 participants 90 participants
47.9 41.5 36.7
Dengue Virus Serotype 1: Pre-injection 3 Number Analyzed 47 participants 50 participants 84 participants
19.1 28.0 39.3
Dengue Virus Serotype 1: 28 days Post-injection 3 Number Analyzed 42 participants 49 participants 84 participants
50.0 51.0 59.5
Dengue Virus Serotype 2: Pre-injection 1 Number Analyzed 54 participants 54 participants 103 participants
0.0 0.0 0.0
Dengue Virus Serotype 2: 28 days Post-injection 1 Number Analyzed 54 participants 54 participants 103 participants
48.1 40.7 33.0
Dengue Virus Serotype 2: Pre-injection 2 Number Analyzed 50 participants 53 participants 100 participants
46.0 60.4 33.0
Dengue Virus Serotype 2: 28 days Post-injection 2 Number Analyzed 48 participants 53 participants 90 participants
83.3 79.2 68.9
Dengue Virus Serotype 2: Pre-injection 3 Number Analyzed 47 participants 51 participants 86 participants
55.3 72.5 57.0
Dengue Virus Serotype 2: 28 days Post-injection 3 Number Analyzed 42 participants 49 participants 84 participants
83.3 79.6 83.3
Dengue Virus Serotype 3: Pre-injection 1 Number Analyzed 54 participants 54 participants 103 participants
0.0 0.0 0.0
Dengue Virus Serotype 3: 28 days Post-injection 1 Number Analyzed 54 participants 52 participants 103 participants
50.0 61.5 21.4
Dengue Virus Serotype 3: Pre-injection 2 Number Analyzed 51 participants 53 participants 100 participants
41.2 60.4 26.0
Dengue Virus Serotype 3: 28 days Post-injection 2 Number Analyzed 48 participants 53 participants 90 participants
68.8 75.5 52.2
Dengue Virus Serotype 3: Pre-injection 3 Number Analyzed 47 participants 50 participants 86 participants
63.8 68.0 50.0
Dengue Virus Serotype 3: 28 days Post-injection 3 Number Analyzed 42 participants 48 participants 83 participants
85.7 85.4 73.5
Dengue Virus Serotype 4: Pre-injection 1 Number Analyzed 54 participants 54 participants 103 participants
0.0 0.0 0.0
Dengue Virus Serotype 4: 28 days Post-injection 1 Number Analyzed 54 participants 52 participants 102 participants
70.4 75.0 46.1
Dengue Virus Serotype 4: Pre-injection 2 Number Analyzed 50 participants 52 participants 100 participants
66.0 73.1 41.0
Dengue Virus Serotype 4: 28 days Post-injection 2 Number Analyzed 48 participants 52 participants 90 participants
87.5 82.7 67.8
Dengue Virus Serotype 4: Pre-injection 3 Number Analyzed 47 participants 49 participants 85 participants
80.9 79.6 77.6
Dengue Virus Serotype 4: 28 days Post-injection 3 Number Analyzed 42 participants 48 participants 83 participants
95.2 83.3 84.3
11.Secondary Outcome
Title Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Hide Description Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions: Pain: significant; prevents daily activity; Erythema and Swelling: >100 mm.
Time Frame Within 7 days after any injection
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety Analysis set which included participants who received at least one injection of CYD dengue vaccine or YF vaccine. Here, “Overall number of participants analyzed” signifies participants evaluable for this outcome measure.
Arm/Group Title CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and Yellow Fever Vaccine: Group 3 Yellow Fever Vaccine: Group 4
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine ; one each at 0, 6 and 12 months.
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
Participants received single dose of YF vaccine at Day 0.
Overall Number of Participants Analyzed 118 119 115 27
Measure Type: Count of Participants
Unit of Measure: Participants
Any Injection site Pain: CYD Dengue Vaccine
44
  37.3%
59
  49.6%
51
  44.3%
NA [1] 
Grade 3 Pain: CYD Dengue Vaccine
0
   0.0%
3
   2.5%
1
   0.9%
NA [1] 
Any Injection site Pain: Yellow Fever Vaccine NA [2]  NA [2] 
53
  46.1%
10
  37.0%
Grade 3 Pain: Yellow Fever Vaccine NA [2]  NA [2] 
1
   0.9%
0
   0.0%
Any Injection site Erythema: CYD Dengue Vaccine
5
   4.2%
10
   8.4%
1
   0.9%
NA [1] 
Grade 3 Erythema: CYD Dengue Vaccine
0
   0.0%
0
   0.0%
0
   0.0%
NA [1] 
Any Injection site Erythema: Yellow Fever Vaccine NA [2]  NA [2] 
5
   4.3%
0
   0.0%
Grade 3 Erythema: Yellow Fever Vaccine NA [2]  NA [2] 
0
   0.0%
0
   0.0%
Any Injection site Swelling: CYD Dengue Vaccine
5
   4.2%
2
   1.7%
0
   0.0%
NA [1] 
Grade 3 Swelling: CYD Dengue Vaccine
0
   0.0%
0
   0.0%
0
   0.0%
NA [1] 
Any Injection site Swelling: Yellow Fever Vaccine NA [2]  NA [2] 
2
   1.7%
0
   0.0%
Grade 3 Swelling: Yellow Fever Vaccine NA [2]  NA [2] 
0
   0.0%
0
   0.0%
[1]
CYD Dengue vaccine was not administered to the specified group.
[2]
Yellow Fever vaccine was not administered to the specified group.
12.Secondary Outcome
Title Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine
Hide Description Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: >= 39.0°C; Headache, Malaise, Myalgia, and Asthenia: significant; prevents daily activity.
Time Frame Within 14 days after any injection
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety 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 Yellow Fever Vaccine: Group 3 Yellow Fever Vaccine: Group 4
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine ; one each at 0, 6 and 12 months.
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months.
Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0.
Participants received single dose of YF vaccine at Day 0.
Overall Number of Participants Analyzed 120 120 119 30
Measure Type: Count of Participants
Unit of Measure: Participants
Fever: Any Grade Number Analyzed 117 participants 119 participants 115 participants 26 participants
7
   6.0%
5
   4.2%
4
   3.5%
1
   3.8%
Fever: Grade 3 Number Analyzed 117 participants 119 participants 115 participants 26 participants
1
   0.9%
1
   0.8%
0
   0.0%
0
   0.0%
Headache: Any Grade Number Analyzed 118 participants 119 participants 115 participants 27 participants
59
  50.0%
60
  50.4%
64
  55.7%
11
  40.7%
Headache: Grade 3 Number Analyzed 118 participants 119 participants 115 participants 27 participants
4
   3.4%
5
   4.2%
6
   5.2%
1
   3.7%
Malaise: Any Grade Number Analyzed 118 participants 119 participants 115 participants 27 participants
63
  53.4%
53
  44.5%
53
  46.1%
12
  44.4%
Malaise: Grade 3 Number Analyzed 118 participants 119 participants 115 participants 27 participants
10
   8.5%
8
   6.7%
10
   8.7%
3
  11.1%
Myalgia: Any Grade Number Analyzed 118 participants 119 participants 115 participants 27 participants
51
  43.2%
47
  39.5%
54
  47.0%
8
  29.6%
Myalgia: Grade 3 Number Analyzed 118 participants 119 participants 115 participants 27 participants
6
   5.1%
3
   2.5%
9
   7.8%
2
   7.4%
Asthenia: Any Grade Number Analyzed 118 participants 119 participants 115 participants 27 participants
41
  34.7%
36
  30.3%
40
  34.8%
9
  33.3%
Asthenia: Grade 3 Number Analyzed 118 participants 119 participants 115 participants 27 participants
6
   5.1%
5
   4.2%
6
   5.2%
2
   7.4%
Time Frame Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine and/or YF 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 after the first injection).
Adverse Event Reporting Description Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (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 Yellow Fever Vaccine: Group 3 Yellow Fever Vaccine: Group 4
Hide Arm/Group Description Participants received 3 doses of CYD dengue vaccine; one each at 0, 6 and 12 months. Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months. Participants received 3 doses of CYD dengue vaccine; one each at 0, 2 and 6 months, and single dose of YF vaccine at Day 0. Participants received single dose of YF vaccine at Day 0.
All-Cause Mortality
CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and Yellow Fever Vaccine: Group 3 Yellow Fever Vaccine: Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/120 (0.00%)      0/120 (0.00%)      0/119 (0.00%)      0/30 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
CYD Dengue Vaccine: Group 1 CYD Dengue Vaccine: Group 2 CYD Dengue and Yellow Fever Vaccine: Group 3 Yellow Fever Vaccine: Group 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/120 (3.33%)      4/120 (3.33%)      5/119 (4.20%)      0/30 (0.00%)    
Hepatobiliary disorders         
Cholecystitis Acute  1  1/120 (0.83%)  1 0/120 (0.00%)  0 0/119 (0.00%)  0 0/30 (0.00%)  0
Infections and infestations         
Abdominal Abscess  1  0/120 (0.00%)  0 1/120 (0.83%)  1 0/119 (0.00%)  0 0/30 (0.00%)  0
Appendicitis  1  1/120 (0.83%)  1 0/120 (0.00%)  0 0/119 (0.00%)  0 0/30 (0.00%)  0
Diverticulitis  1  1/120 (0.83%)  1 0/120 (0.00%)  0 0/119 (0.00%)  0 0/30 (0.00%)  0
Pneumonia  1  1/120 (0.83%)  1 0/120 (0.00%)  0 0/119 (0.00%)  0 0/30 (0.00%)  0
Injury, poisoning and procedural complications         
Femur Fracture  1  0/120 (0.00%)  0 0/120 (0.00%)  0 1/119 (0.84%)  1 0/30 (0.00%)  0
Rib Fracture  1  0/120 (0.00%)  0 0/120 (0.00%)  0 1/119 (0.84%)  1 0/30 (0.00%)  0
Toxicity To Various Agents  1  0/120 (0.00%)  0 0/120 (0.00%)  0 1/119 (0.84%)  1 0/30 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal Cell Carcinoma  1  0/120 (0.00%)  0 1/120 (0.83%)  1 0/119 (0.00%)  0 0/30 (0.00%)  0
Breast Cancer  1  0/120 (0.00%)  0 0/120 (0.00%)  0 1/119 (0.84%)  1 0/30 (0.00%)  0
Squamous Cell Carcinoma  1  0/120 (0.00%)  0 1/120 (0.83%)  1 0/119 (0.00%)  0 0/30 (0.00%)  0
Vaginal Cancer  1  1/120 (0.83%)  1 0/120 (0.00%)  0 0/119 (0.00%)  0 0/30 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Blighted Ovum  1  1/120 (0.83%)  1 0/120 (0.00%)  0 0/119 (0.00%)  0 0/30 (0.00%)  0
Psychiatric disorders         
Suicidal Ideation  1  0/120 (0.00%)  0 1/120 (0.83%)  1 0/119 (0.00%)  0 0/30 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma  1  0/120 (0.00%)  0 1/120 (0.83%)  1 0/119 (0.00%)  0 0/30 (0.00%)  0
Atelectasis  1  0/120 (0.00%)  0 1/120 (0.83%)  1 0/119 (0.00%)  0 0/30 (0.00%)  0
Pneumothorax  1  0/120 (0.00%)  0 0/120 (0.00%)  0 1/119 (0.84%)  1 0/30 (0.00%)  0
Vascular disorders         
Thrombosis  1  0/120 (0.00%)  0 0/120 (0.00%)  0 1/119 (0.84%)  1 0/30 (0.00%)  0
1
Term from vocabulary, MedDra version 14.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events 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 Yellow Fever Vaccine: Group 3 Yellow Fever Vaccine: Group 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   91/120 (75.83%)      92/120 (76.67%)      92/119 (77.31%)      17/30 (56.67%)    
Gastrointestinal disorders         
Nausea  1  4/120 (3.33%)  5 7/120 (5.83%)  7 1/119 (0.84%)  1 0/30 (0.00%)  0
General disorders         
Asthenia  1  41/120 (34.17%)  57 36/120 (30.00%)  61 40/119 (33.61%)  57 9/30 (30.00%)  9
Fatigue  1  1/120 (0.83%)  1 4/120 (3.33%)  4 1/119 (0.84%)  1 2/30 (6.67%)  2
Injection Site Erythema  1  5/120 (4.17%)  5 10/120 (8.33%)  11 5/119 (4.20%)  6 0/30 (0.00%)  0
Injection Site Pain  1  44/120 (36.67%)  71 59/120 (49.17%)  97 63/119 (52.94%)  138 10/30 (33.33%)  10
Malaise  1  63/120 (52.50%)  92 53/120 (44.17%)  93 53/119 (44.54%)  77 12/30 (40.00%)  12
Pyrexia  1  7/120 (5.83%)  7 6/120 (5.00%)  6 5/119 (4.20%)  5 1/30 (3.33%)  1
Infections and infestations         
Nasopharyngitis  1  5/120 (4.17%)  6 7/120 (5.83%)  8 2/119 (1.68%)  2 0/30 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Myalgia  1  51/120 (42.50%)  75 47/120 (39.17%)  78 54/119 (45.38%)  91 8/30 (26.67%)  8
Nervous system disorders         
Headache  1  60/120 (50.00%)  90 61/120 (50.83%)  110 64/119 (53.78%)  110 11/30 (36.67%)  11
Respiratory, thoracic and mediastinal disorders         
Cough  1  2/120 (1.67%)  2 4/120 (3.33%)  4 7/119 (5.88%)  7 0/30 (0.00%)  0
Oropharyngeal Pain  1  5/120 (4.17%)  5 7/120 (5.83%)  7 4/119 (3.36%)  4 0/30 (0.00%)  0
1
Term from vocabulary, MedDra version 14.0
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.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01488890     History of Changes
Other Study ID Numbers: CYD51
U1111-1122-1892 ( Other Identifier: WHO )
First Submitted: December 6, 2011
First Posted: December 8, 2011
Results First Submitted: May 24, 2019
Results First Posted: June 14, 2019
Last Update Posted: June 14, 2019