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Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia

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ClinicalTrials.gov Identifier: NCT01134263
Recruitment Status : Completed
First Posted : May 31, 2010
Results First Posted : July 24, 2019
Last Update Posted : July 24, 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: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Dengue Fever
Dengue Hemorrhagic Fever
Interventions Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus
Biological: Placebo: NaCl 0.9%
Enrollment 715
Recruitment Details Study participants were enrolled from 05 October 2010 to 26 November 2010 at 8 study sites in Australia.
Pre-assignment Details A total of 715 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled in the study.
Arm/Group Title CYD Dengue Vaccine Phase III Lot 1 CYD Dengue Vaccine Phase III Lot 2 CYD Dengue Vaccine Phase III Lot 3 CYD Dengue Vaccine Phase II Lot Placebo
Hide Arm/Group Description Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Period Title: Overall Study
Started 164 163 163 168 57
Received Vaccination 1 163 162 163 167 57
Received Vaccination 2 151 152 139 154 53
Received Vaccination 3 140 145 134 151 49
Safety Population [1] 163 161 164 [2] 167 57
Completed 140 143 134 149 48
Not Completed 24 20 29 19 9
Reason Not Completed
Serious adverse event             2             1             1             1             1
Other adverse event             1             2             5             3             0
Protocol Violation             8             7             2             4             2
Lost to Follow-up             4             3             5             3             1
Withdrawal by Subject             8             6             16             7             5
Enrolled, but not treated             1             1             0             1             0
[1]
Safety Population:All participants who received study drug, analyzed according to treatment received
[2]
1 participant randomized to the Phase III Lot 2 group, received Phase III Lot 3 vaccination.
Arm/Group Title CYD Dengue Vaccine Phase III Lot 1 CYD Dengue Vaccine Phase III Lot 2 CYD Dengue Vaccine Phase III Lot 3 CYD Dengue Vaccine Phase II Lot Placebo Total
Hide Arm/Group Description Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. Participants received 3 doses of 0.5 ml CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. Participants received 3 doses of 0.5 ml CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months, subcutaneously. Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. Total of all reporting groups
Overall Number of Baseline Participants 163 162 163 167 57 712
Hide Baseline Analysis Population Description
Analysis was performed on Full Analysis Set included all participants who received at least 1 injection of CYD Dengue Vaccine or placebo.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 163 participants 162 participants 163 participants 167 participants 57 participants 712 participants
39.4  (13.3) 39.4  (12.9) 38.7  (14.1) 38.4  (13.2) 39.7  (13.5) 39.0  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 162 participants 163 participants 167 participants 57 participants 712 participants
Female
103
  63.2%
87
  53.7%
84
  51.5%
84
  50.3%
33
  57.9%
391
  54.9%
Male
60
  36.8%
75
  46.3%
79
  48.5%
83
  49.7%
24
  42.1%
321
  45.1%
1.Primary Outcome
Title Post-Dose 3 Geometric Mean Titers (GMTs) of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Phase III Lots of CYD Dengue Vaccine
Hide Description GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using the plaque reduction neutralization test (PRNT) assay. The lot-to-lot consistency between 3 Phase III lots was based on the use of the two-sided 95% confidence interval (CI) of the differences of the means of the log10 transformed post-vaccination titers between pairs of lots.
Time Frame 28 days post-injection 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Per-protocol analysis set which included participants who received at least 1 dose of the study vaccine or placebo and had no protocol deviations. Data for this outcome measure was not planned to be collected and analyzed for Phase II Lot and placebo.
Arm/Group Title CYD Dengue Vaccine Phase III Lot 1 CYD Dengue Vaccine Phase III Lot 2 CYD Dengue Vaccine Phase III Lot 3
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month12 (vaccination 3), subcutaneously.
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month12 (vaccination 3) , subcutaneously.
Overall Number of Participants Analyzed 129 123 124
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer (1/dilution)
Dengue Virus Serotype 1
20.6
(16.9 to 25.1)
18.1
(14.8 to 22.2)
17.1
(13.9 to 21.2)
Dengue Virus Serotype 2
65.9
(50.6 to 85.7)
44.1
(33.3 to 58.3)
58.1
(43.2 to 78.2)
Dengue Virus Serotype 3
74.2
(60.1 to 91.7)
65
(53.2 to 79.3)
71.6
(58.2 to 88.2)
Dengue Virus Serotype 4
131.8
(101.4 to 171.3)
94.6
(75.3 to 118.7)
108.5
(84.2 to 139.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Phase III Lot 1, CYD Dengue Vaccine Phase III Lot 2
Comments Dengue Virus Serotype 1: Phase III Lot 1 vs Lot 2
Type of Statistical Test Equivalence
Comments Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
Method of Estimation Estimation Parameter Difference of Log10 GMT
Estimated Value 0.055
Confidence Interval (2-Sided) 95%
-0.067 to 0.178
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Phase III Lot 2, CYD Dengue Vaccine Phase III Lot 3
Comments Dengue Virus Serotype 1: Phase III Lot 2 vs Lot 3
Type of Statistical Test Equivalence
Comments Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
Method of Estimation Estimation Parameter Difference of Log10 GMT
Estimated Value 0.024
Confidence Interval (2-Sided) 95%
-0.102 to 0.151
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Phase III Lot 1, CYD Dengue Vaccine Phase III Lot 3
Comments Dengue Virus Serotype 1: Phase III Lot 3 vs Lot 1
Type of Statistical Test Equivalence
Comments Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
Method of Estimation Estimation Parameter Difference of Log10 GMT
Estimated Value -0.080
Confidence Interval (2-Sided) 95%
-0.204 to 0.045
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Phase III Lot 1, CYD Dengue Vaccine Phase III Lot 2
Comments Dengue Virus Serotype 2: Phase III Lot 1 vs Lot 2
Type of Statistical Test Equivalence
Comments Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
Method of Estimation Estimation Parameter Difference of Log10 GMT
Estimated Value 0.174
Confidence Interval (2-Sided) 95%
0.009 to 0.340
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Phase III Lot 2, CYD Dengue Vaccine Phase III Lot 3
Comments Dengue Virus Serotype 2: Phase III Lot 2 vs Lot 3
Type of Statistical Test Equivalence
Comments Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
Method of Estimation Estimation Parameter Difference of Log10 GMT
Estimated Value -0.120
Confidence Interval (2-Sided) 95%
-0.297 to 0.056
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Phase III Lot 1, CYD Dengue Vaccine Phase III Lot 3
Comments Dengue Virus Serotype 2: Phase III Lot 3 vs Lot 1
Type of Statistical Test Equivalence
Comments Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
Method of Estimation Estimation Parameter Difference of Log10 GMT
Estimated Value -0.054
Confidence Interval (2-Sided) 95%
-0.225 to 0.117
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Phase III Lot 1, CYD Dengue Vaccine Phase III Lot 2
Comments Dengue Virus Serotype 3: Phase III Lot 1 vs Lot 2
Type of Statistical Test Equivalence
Comments Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
Method of Estimation Estimation Parameter Difference of Log10 GMT
Estimated Value 0.058
Confidence Interval (2-Sided) 95%
-0.068 to 0.184
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Phase III Lot 2, CYD Dengue Vaccine Phase III Lot 3
Comments Dengue Virus Serotype 3: Phase III Lot 2 vs Lot 3
Type of Statistical Test Equivalence
Comments Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
Method of Estimation Estimation Parameter Difference of Log10 GMT
Estimated Value -0.042
Confidence Interval (2-Sided) 95%
-0.167 to 0.082
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Phase III Lot 1, CYD Dengue Vaccine Phase III Lot 3
Comments Dengue Virus Serotype 3: Phase III Lot 3 vs Lot 1
Type of Statistical Test Equivalence
Comments Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
Method of Estimation Estimation Parameter Difference of Log10 GMT
Estimated Value -0.016
Confidence Interval (2-Sided) 95%
-0.144 to 0.113
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Phase III Lot 1, CYD Dengue Vaccine Phase III Lot 2
Comments Dengue Virus Serotype 4: Phase III Lot 1 vs Lot 2
Type of Statistical Test Equivalence
Comments Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
Method of Estimation Estimation Parameter Difference of Log10 GMT
Estimated Value 0.144
Confidence Interval (2-Sided) 95%
-0.006 to 0.295
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Phase III Lot 2, CYD Dengue Vaccine Phase III Lot 3
Comments Dengue Virus Serotype 4: Phase III Lot 2 vs Lot 3
Type of Statistical Test Equivalence
Comments Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
Method of Estimation Estimation Parameter Difference of Log10 GMT
Estimated Value -0.060
Confidence Interval (2-Sided) 95%
-0.207 to 0.088
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Phase III Lot 1, CYD Dengue Vaccine Phase III Lot 3
Comments Dengue Virus Serotype 4: Phase III Lot 3 vs Lot 1
Type of Statistical Test Equivalence
Comments Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.
Method of Estimation Estimation Parameter Difference of Log10 GMT
Estimated Value -0.085
Confidence Interval (2-Sided) 95%
-0.242 to 0.073
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Geometric Mean Titers of Antibodies Against Each of the Four Dengue Virus Serotypes Following Vaccination With Pooled Phase III Lots (1, 2 or 3 )and Phase II Lot of CYD Dengue Vaccine
Hide Description GMTs against each of the 4 serotypes (serotype 1, serotype 2, serotype 3 and serotype 4) of dengue virus strains were assessed using PRNT assay. Equivalence of Phase III vaccine with Phase II vaccine was assessed by Bridging between Phase III and Phase II Lot of CYD Dengue Vaccine.
Time Frame 28 days post-Injection 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Per Protocol 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 placebo.
Arm/Group Title CYD Dengue Vaccine Pooled Phase III Lot CYD Dengue Vaccine Phase II Lot
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3) from any of the Phase III Lots 1, 2 or 3.
Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Overall Number of Participants Analyzed 376 128
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer (1/dilution)
Dengue Virus Serotype 1 Number Analyzed 376 participants 128 participants
18.6
(16.5 to 20.9)
15.1
(12.4 to 18.4)
Dengue Virus Serotype 2 Number Analyzed 376 participants 128 participants
55.4
(47.2 to 65.1)
25.7
(20.6 to 32)
Dengue Virus Serotype 3 Number Analyzed 376 participants 128 participants
70.2
(62.4 to 79.1)
83.6
(71.1 to 98.4)
Dengue Virus Serotype 4 Number Analyzed 376 participants 127 participants
110.9
(96.1 to 127.9)
115.4
(92.8 to 143.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Pooled Phase III Lot, CYD Dengue Vaccine Phase II Lot
Comments Dengue Virus Serotype 1
Type of Statistical Test Equivalence
Comments Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was > -0.301 and the upper limit was < 0.301.
Method of Estimation Estimation Parameter Difference of Log10 GMT
Estimated Value 0.091
Confidence Interval (2-Sided) 95%
-0.009 to 0.192
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Pooled Phase III Lot, CYD Dengue Vaccine Phase II Lot
Comments Dengue Virus Serotype 2
Type of Statistical Test Equivalence
Comments Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was > -0.301 and the upper limit was < 0.301.
Method of Estimation Estimation Parameter Difference of Log10 GMT
Estimated Value 0.334
Confidence Interval (2-Sided) 95%
0.202 to 0.466
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Pooled Phase III Lot, CYD Dengue Vaccine Phase II Lot
Comments Dengue Virus Serotype 3
Type of Statistical Test Equivalence
Comments Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was > -0.301 and the upper limit was < 0.301.
Method of Estimation Estimation Parameter Difference of Log10 GMT
Estimated Value -0.076
Confidence Interval (2-Sided) 95%
-0.173 to 0.021
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Pooled Phase III Lot, CYD Dengue Vaccine Phase II Lot
Comments Dengue Virus Serotype 4
Type of Statistical Test Equivalence
Comments Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was > -0.301 and the upper limit was < 0.301.
Method of Estimation Estimation Parameter Difference of Log10 GMT
Estimated Value -0.017
Confidence Interval (2-Sided) 95%
-0.137 to 0.103
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Hide Description Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: Significant; prevents daily activity. Erythema and Swelling: Grade 3: > 10 cm. Participants with Injection Site Reactions of any Grade (1, 2 or 3) and grade 3 were reported.
Time Frame 7 days post any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety Analysis Set which included all participants who received the study dose, and participants were analyzed according to the treatment received. Here, ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Phase III Lot 1 CYD Dengue Vaccine Phase III Lot 2 CYD Dengue Vaccine Phase III Lot 3 CYD Dengue Vaccine Phase II Lot Placebo
Hide Arm/Group Description:
Participants received 3 doses of 0.5 ml CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Overall Number of Participants Analyzed 163 161 164 167 57
Measure Type: Count of Participants
Unit of Measure: Participants
Pain: Any Number Analyzed 162 participants 160 participants 159 participants 164 participants 57 participants
73
  45.1%
74
  46.3%
73
  45.9%
78
  47.6%
11
  19.3%
Pain: Grade 3 Number Analyzed 162 participants 160 participants 159 participants 164 participants 57 participants
1
   0.6%
1
   0.6%
1
   0.6%
0
   0.0%
0
   0.0%
Erythema: Any Number Analyzed 162 participants 160 participants 159 participants 164 participants 57 participants
22
  13.6%
15
   9.4%
25
  15.7%
24
  14.6%
0
   0.0%
Erythema: Grade 3 Number Analyzed 162 participants 160 participants 159 participants 164 participants 57 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Swelling: Any Number Analyzed 162 participants 160 participants 159 participants 164 participants 57 participants
8
   4.9%
4
   2.5%
2
   1.3%
5
   3.0%
1
   1.8%
Swelling: Grade 3 Number Analyzed 162 participants 160 participants 159 participants 164 participants 57 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Number of Participants With Solicited Systemic Reactions After Any Vaccination
Hide Description Solicited systemic reactions: Asthenia, Fever, Headache, Malaise and Myalgia. Fever: Grade 3: >=39.0°C (>=102.1°F). Headache, malaise, myalgia and asthenia: Grade 3: significant; prevents daily activity. Participants with systemic reactions of any Grade (1, 2 or 3) and grade 3 were reported.
Time Frame 14 days post any vaccination
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 Phase III Lot 1 CYD Dengue Vaccine Phase III Lot 2 CYD Dengue Vaccine Phase III Lot 3 CYD Dengue Vaccine Phase II Lot Placebo
Hide Arm/Group Description:
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0(vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
Overall Number of Participants Analyzed 163 161 164 167 57
Measure Type: Count of Participants
Unit of Measure: Participants
Asthenia: Any Number Analyzed 162 participants 160 participants 159 participants 164 participants 57 participants
49
  30.2%
51
  31.9%
57
  35.8%
69
  42.1%
20
  35.1%
Asthenia: Grade 3 Number Analyzed 162 participants 160 participants 159 participants 164 participants 57 participants
3
   1.9%
9
   5.6%
11
   6.9%
9
   5.5%
2
   3.5%
Fever: Any Number Analyzed 162 participants 159 participants 159 participants 164 participants 57 participants
5
   3.1%
8
   5.0%
8
   5.0%
5
   3.0%
1
   1.8%
Fever: Grade 3 Number Analyzed 162 participants 159 participants 159 participants 164 participants 57 participants
0
   0.0%
0
   0.0%
1
   0.6%
0
   0.0%
0
   0.0%
Headache: Any Number Analyzed 162 participants 160 participants 159 participants 164 participants 57 participants
100
  61.7%
96
  60.0%
108
  67.9%
104
  63.4%
28
  49.1%
Headache: Grade 3 Number Analyzed 162 participants 160 participants 159 participants 164 participants 57 participants
8
   4.9%
22
  13.8%
17
  10.7%
14
   8.5%
4
   7.0%
Malaise: Any Number Analyzed 162 participants 160 participants 159 participants 164 participants 57 participants
72
  44.4%
75
  46.9%
97
  61.0%
90
  54.9%
26
  45.6%
Malaise: Grade 3 Number Analyzed 162 participants 160 participants 159 participants 164 participants 57 participants
10
   6.2%
17
  10.6%
19
  11.9%
13
   7.9%
3
   5.3%
Myalgia: Any Number Analyzed 162 participants 160 participants 159 participants 164 participants 57 participants
70
  43.2%
69
  43.1%
71
  44.7%
84
  51.2%
21
  36.8%
Myalgia: Grade 3 Number Analyzed 162 participants 160 participants 159 participants 164 participants 57 participants
4
   2.5%
10
   6.3%
11
   6.9%
13
   7.9%
3
   5.3%
Time Frame Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 28 days after each dose of CYD dengue vaccine or Placebo. Solicited Reaction (SR) data were collected within 7 and 14 days after each vaccination. Serious adverse event (SAE) data were collected throughout the study, up to 30 days post-vaccination 3 (up to Month 13).
Adverse Event Reporting Description Analysis was performed on Safety Analysis Set.
 
Arm/Group Title CYD Dengue Vaccine Phase III Lot 1 CYD Dengue Vaccine Phase III Lot 2 CYD Dengue Vaccine Phase III Lot 3 CYD Dengue Vaccine Phase II Lot Placebo
Hide Arm/Group Description Participants received 3 doses of CYD dengue vaccine (Phase III Lot 1), one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. Participants received 3 doses of CYD dengue vaccine (Phase III Lot 2) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. Participants received 3 doses of CYD dengue vaccine (Phase III Lot 3) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. Participants received 3 doses of CYD dengue vaccine (Phase II Lot) one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously. Participants received placebo matched to CYD dengue vaccine, one each at Day 0 (vaccination 1), Month 6 (vaccination 2), and Month 12 (vaccination 3), subcutaneously.
All-Cause Mortality
CYD Dengue Vaccine Phase III Lot 1 CYD Dengue Vaccine Phase III Lot 2 CYD Dengue Vaccine Phase III Lot 3 CYD Dengue Vaccine Phase II Lot Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/163 (0.00%)      0/161 (0.00%)      0/164 (0.00%)      0/167 (0.00%)      0/57 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
CYD Dengue Vaccine Phase III Lot 1 CYD Dengue Vaccine Phase III Lot 2 CYD Dengue Vaccine Phase III Lot 3 CYD Dengue Vaccine Phase II Lot Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/163 (6.13%)      9/161 (5.59%)      5/164 (3.05%)      9/167 (5.39%)      1/57 (1.75%)    
Cardiac disorders           
Stress Cardiomyopathy  1  1/163 (0.61%)  1 0/161 (0.00%)  0 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Gastrointestinal disorders           
Abdominal Pain  1  0/163 (0.00%)  0 1/161 (0.62%)  1 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Inguinal Hernia  1  0/163 (0.00%)  0 0/161 (0.00%)  0 1/164 (0.61%)  1 0/167 (0.00%)  0 0/57 (0.00%)  0
Pancreatitis  1  0/163 (0.00%)  0 0/161 (0.00%)  0 1/164 (0.61%)  1 0/167 (0.00%)  0 0/57 (0.00%)  0
Pancreatitis Acute  1  1/163 (0.61%)  1 0/161 (0.00%)  0 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
General disorders           
Chest Pain  1  0/163 (0.00%)  0 0/161 (0.00%)  0 0/164 (0.00%)  0 1/167 (0.60%)  1 0/57 (0.00%)  0
Pyrexia  1  0/163 (0.00%)  0 0/161 (0.00%)  0 1/164 (0.61%)  1 0/167 (0.00%)  0 0/57 (0.00%)  0
Hepatobiliary disorders           
Cholecystitis  1  0/163 (0.00%)  0 1/161 (0.62%)  1 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Cholelithiasis  1  0/163 (0.00%)  0 0/161 (0.00%)  0 0/164 (0.00%)  0 1/167 (0.60%)  1 0/57 (0.00%)  0
Immune system disorders           
Hypersensitivity  1  0/163 (0.00%)  0 1/161 (0.62%)  1 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Infections and infestations           
Appendicitis  1  0/163 (0.00%)  0 0/161 (0.00%)  0 0/164 (0.00%)  0 1/167 (0.60%)  1 0/57 (0.00%)  0
Bartholin's Abscess  1  0/163 (0.00%)  0 1/161 (0.62%)  1 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Cellulitis  1  1/163 (0.61%)  1 1/161 (0.62%)  1 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Groin Abscess  1  1/163 (0.61%)  1 0/161 (0.00%)  0 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Skin Infection  1  0/163 (0.00%)  0 0/161 (0.00%)  0 0/164 (0.00%)  0 0/167 (0.00%)  0 1/57 (1.75%)  1
Injury, poisoning and procedural complications           
Fall  1  0/163 (0.00%)  0 0/161 (0.00%)  0 0/164 (0.00%)  0 1/167 (0.60%)  1 0/57 (0.00%)  0
Foreign Body  1  0/163 (0.00%)  0 0/161 (0.00%)  0 0/164 (0.00%)  0 1/167 (0.60%)  1 0/57 (0.00%)  0
Ligament Rupture  1  1/163 (0.61%)  1 0/161 (0.00%)  0 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Muscle Rupture  1  1/163 (0.61%)  1 0/161 (0.00%)  0 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Metabolism and nutrition disorders           
Diabetic Ketoacidosis  1  1/163 (0.61%)  1 0/161 (0.00%)  0 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Type 2 Diabetes Mellitus  1  1/163 (0.61%)  1 0/161 (0.00%)  0 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Haemarthrosis  1  0/163 (0.00%)  0 1/161 (0.62%)  1 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Intervertebral Disc Protrusion  1  1/163 (0.61%)  1 0/161 (0.00%)  0 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Osteoarthritis  1  0/163 (0.00%)  0 0/161 (0.00%)  0 0/164 (0.00%)  0 1/167 (0.60%)  1 0/57 (0.00%)  0
Polymyalgia Rheumatica  1  0/163 (0.00%)  0 0/161 (0.00%)  0 0/164 (0.00%)  0 1/167 (0.60%)  1 0/57 (0.00%)  0
Tendonitis  1  0/163 (0.00%)  0 1/161 (0.62%)  1 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Hypergammaglobulinaemia Benign Monoclonal  1  1/163 (0.61%)  1 0/161 (0.00%)  0 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Malignant Melanoma  1  1/163 (0.61%)  1 0/161 (0.00%)  0 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Malignant Melanoma In Situ  1  0/163 (0.00%)  0 1/161 (0.62%)  1 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Prostate Cancer  1  0/163 (0.00%)  0 0/161 (0.00%)  0 0/164 (0.00%)  0 0/167 (0.00%)  0 1/57 (1.75%)  1
Nervous system disorders           
Headache  1  0/163 (0.00%)  0 1/161 (0.62%)  1 1/164 (0.61%)  1 0/167 (0.00%)  0 0/57 (0.00%)  0
Paraesthesia  1  0/163 (0.00%)  0 0/161 (0.00%)  0 0/164 (0.00%)  0 1/167 (0.60%)  1 0/57 (0.00%)  0
Transient Ischaemic Attack  1  0/163 (0.00%)  0 0/161 (0.00%)  0 1/164 (0.61%)  3 0/167 (0.00%)  0 0/57 (0.00%)  0
Psychiatric disorders           
Anxiety  1  0/163 (0.00%)  0 1/161 (0.62%)  4 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Renal and urinary disorders           
Calculus Ureteric  1  1/163 (0.61%)  1 0/161 (0.00%)  0 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Nephritis  1  0/163 (0.00%)  0 1/161 (0.62%)  1 0/164 (0.00%)  0 0/167 (0.00%)  0 0/57 (0.00%)  0
Reproductive system and breast disorders           
Pelvic Pain  1  0/163 (0.00%)  0 0/161 (0.00%)  0 0/164 (0.00%)  0 1/167 (0.60%)  1 0/57 (0.00%)  0
1
Term from vocabulary, MedDra version 13.0
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 Phase III Lot 1 CYD Dengue Vaccine Phase III Lot 2 CYD Dengue Vaccine Phase III Lot 3 CYD Dengue Vaccine Phase II Lot Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   136/163 (83.44%)      131/161 (81.37%)      135/164 (82.32%)      140/167 (83.83%)      41/57 (71.93%)    
Gastrointestinal disorders           
Toothache  1  1/163 (0.61%)  1 2/161 (1.24%)  3 4/164 (2.44%)  4 1/167 (0.60%)  4 3/57 (5.26%)  3
General disorders           
Asthenia  1  49/163 (30.06%)  66 51/161 (31.68%)  72 58/164 (35.37%)  74 69/167 (41.32%)  90 20/57 (35.09%)  26
Injection Site Erythema  1  22/163 (13.50%)  26 15/161 (9.32%)  20 25/164 (15.24%)  31 24/167 (14.37%)  32 0/57 (0.00%)  0
Injection Site Haematoma  1  12/163 (7.36%)  12 9/161 (5.59%)  11 12/164 (7.32%)  13 10/167 (5.99%)  10 6/57 (10.53%)  6
Injection Site Pain  1  73/163 (44.79%)  122 74/161 (45.96%)  114 73/164 (44.51%)  122 78/167 (46.71%)  122 11/57 (19.30%)  15
Malaise  1  72/163 (44.17%)  110 75/161 (46.58%)  116 97/164 (59.15%)  146 90/167 (53.89%)  126 26/57 (45.61%)  43
Pyrexia  1  6/163 (3.68%)  7 9/161 (5.59%)  11 9/164 (5.49%)  10 5/167 (2.99%)  6 1/57 (1.75%)  1
Infections and infestations           
Nasopharyngitis  1  11/163 (6.75%)  13 6/161 (3.73%)  6 9/164 (5.49%)  11 8/167 (4.79%)  8 4/57 (7.02%)  4
Upper Respiratory Tract Infection  1  13/163 (7.98%)  13 14/161 (8.70%)  15 16/164 (9.76%)  18 14/167 (8.38%)  15 6/57 (10.53%)  7
Musculoskeletal and connective tissue disorders           
Myalgia  1  70/163 (42.94%)  100 69/161 (42.86%)  105 72/164 (43.90%)  111 84/167 (50.30%)  124 21/57 (36.84%)  30
Nervous system disorders           
Headache  1  103/163 (63.19%)  188 97/161 (60.25%)  186 108/164 (65.85%)  208 104/167 (62.28%)  201 28/57 (49.12%)  61
Reproductive system and breast disorders           
Dysmenorrhoea  1  7/163 (4.29%)  9 5/161 (3.11%)  9 2/164 (1.22%)  2 4/167 (2.40%)  5 3/57 (5.26%)  4
Respiratory, thoracic and mediastinal disorders           
Cough  1  9/163 (5.52%)  10 3/161 (1.86%)  3 3/164 (1.83%)  3 6/167 (3.59%)  6 1/57 (1.75%)  1
Oropharyngeal Pain  1  16/163 (9.82%)  17 5/161 (3.11%)  5 7/164 (4.27%)  7 12/167 (7.19%)  13 3/57 (5.26%)  3
1
Term from vocabulary, MedDra version 13.0
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: Trial Transparency Team
Organization: Sanofi Pasteur
EMail: Contact-US@sanofi.com
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Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01134263     History of Changes
Other Study ID Numbers: CYD17
U1111-1114-7646 ( Other Identifier: WHO )
First Submitted: May 27, 2010
First Posted: May 31, 2010
Results First Submitted: May 21, 2019
Results First Posted: July 24, 2019
Last Update Posted: July 24, 2019