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Trial record 1 of 1 for:    CYD32
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Study of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01254422
Recruitment Status : Completed
First Posted : December 6, 2010
Results First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

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, and 4 virus
Biological: Placebo: NaCl 0.9%
Enrollment 250
Recruitment Details Study participants were enrolled from 02 December 2010 to 10 February 2011 at 4 clinical sites in Malaysia.
Pre-assignment Details A total of 250 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description Participants received 3 injections (Inj.) of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Period Title: Overall Study
Started 199 51
Completed 196 50
Not Completed 3 1
Reason Not Completed
Protocol Violation             1             0
Adverse Event             1             0
Serious adverse event             0             1
Lost to Follow-up             1             0
Arm/Group Title CYD Dengue Vaccine Group Placebo Group Total
Hide Arm/Group Description Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. Total of all reporting groups
Overall Number of Baseline Participants 199 51 250
Hide Baseline Analysis Population Description
Analysis was performed on all randomized participants who were randomly assigned to CYD Dengue vaccine Group or Placebo Group.
Age, Customized  
Measure Type: Number
Unit of measure:  Years
Number Analyzed 199 participants 51 participants 250 participants
2 to 5 years 99 26 125
6 to 11 years 100 25 125
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 199 participants 51 participants 250 participants
Female
103
  51.8%
19
  37.3%
122
  48.8%
Male
96
  48.2%
32
  62.7%
128
  51.2%
1.Primary Outcome
Title Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Hide Description Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions: Pain: Incapacitating, unable to perform usual activities; Erythema and Swelling: >=50 millimeter (mm). Grade 3 Solicited systemic reactions: Fever: >=39°Degree Celsius (C); Headache, Malaise, Myalgia, and Asthenia: Significant: Prevents daily activity.
Time Frame Day 0 up to Day 14 post-any and each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety analysis set which included participants who received any dose of CYD dengue vaccine or placebo and were analyzed according to the treatment received at this injection. Here, ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 199 51
Measure Type: Number
Unit of Measure: Percentage of participants
Inj. site Pain; Post-Any Inj. Number Analyzed 199 participants 51 participants
69.3 56.9
Grade 3 Inj. site Pain; Post-Any Inj. Number Analyzed 199 participants 51 participants
1.0 0.0
Inj. site Erythema; Post-Any Inj. Number Analyzed 199 participants 51 participants
46.7 49.0
Grade 3 Inj. site Erythema; Post-Any Inj. Number Analyzed 199 participants 51 participants
0.5 0.0
Inj. site Swelling; Post-Any Inj. Number Analyzed 199 participants 51 participants
38.7 35.3
Grade 3 Inj. site Swelling; Post-Any Inj. Number Analyzed 199 participants 51 participants
0.5 0.0
Inj. site Pain; Post-Inj. 1 Number Analyzed 198 participants 51 participants
41.4 27.5
Grade 3 Inj. site Pain; Post-Inj. 1 Number Analyzed 198 participants 51 participants
0.5 0.0
Inj. site Erythema; Post-Inj. 1 Number Analyzed 198 participants 51 participants
22.2 23.5
Grade 3 Inj. site Erythema; Post-Inj. 1 Number Analyzed 198 participants 51 participants
0.5 0.0
Inj. site Swelling; Post-Inj. 1 Number Analyzed 198 participants 51 participants
18.7 21.6
Grade 3 Inj. site Swelling; Post-Inj. 1 Number Analyzed 198 participants 51 participants
0.0 0.0
Inj. site Pain; Post-Inj. 2 Number Analyzed 197 participants 50 participants
48.2 26.0
Grade 3 Inj. site Pain; Post-Inj. 2 Number Analyzed 197 participants 50 participants
0.5 0.0
Inj. site Erythema; Post-Inj. 2 Number Analyzed 197 participants 50 participants
33.0 32.0
Grade 3 Inj. site Erythema; Post-Inj. 2 Number Analyzed 197 participants 50 participants
0.0 0.0
Inj. site Swelling; Post-Inj. 2 Number Analyzed 197 participants 50 participants
15.2 10.0
Grade 3 Inj. site Swelling; Post-Inj. 2 Number Analyzed 197 participants 50 participants
0.0 0.0
Inj. site Pain; Post-Inj. 3 Number Analyzed 195 participants 50 participants
40.0 38.0
Grade 3 Inj. site Pain; Post-Inj. 3 Number Analyzed 195 participants 50 participants
0.5 0.0
Inj. site Erythema; Post-Inj. 3 Number Analyzed 195 participants 50 participants
23.6 24.0
Grade 3 Inj. site Erythema; Post-Inj. 3 Number Analyzed 195 participants 50 participants
0.0 0.0
Inj. site Swelling; Post-Inj. 3 Number Analyzed 195 participants 50 participants
20.0 24.0
Grade 3 Inj. site Swelling; Post-Inj. 3 Number Analyzed 195 participants 50 participants
0.5 0.0
Asthenia; Post-Any Inj. Number Analyzed 199 participants 51 participants
47.2 33.3
Grade 3 Asthenia; Post-Any Inj. Number Analyzed 199 participants 51 participants
3.0 0.0
Fever; Post-Any Inj. Number Analyzed 198 participants 51 participants
29.3 19.6
Grade 3 Fever; Post-Any Inj. Number Analyzed 198 participants 51 participants
6.6 3.9
Headache; Post-Any Inj. Number Analyzed 199 participants 51 participants
52.3 39.2
Grade 3 Headache; Post-Any Inj. Number Analyzed 199 participants 51 participants
2.0 2.0
Malaise; Post-Any Inj. Number Analyzed 199 participants 51 participants
54.3 41.2
Grade 3 Malaise; Post-Any Inj. Number Analyzed 199 participants 51 participants
3.5 0.0
Myalgia; Post-Any Inj. Number Analyzed 199 participants 51 participants
37.7 31.4
Grade 3 Myalgia; Post-Any Inj. Number Analyzed 199 participants 51 participants
2.5 0.0
Asthenia; Post-Inj. 1 Number Analyzed 199 participants 51 participants
28.1 19.6
Grade 3 Asthenia; Post-Inj. 1 Number Analyzed 199 participants 51 participants
2.0 0.0
Fever; Post-Inj. 1 Number Analyzed 198 participants 49 participants
12.6 8.2
Grade 3 Fever; Post-Inj. 1 Number Analyzed 198 participants 49 participants
2.0 4.1
Headache; Post-Inj. 1 Number Analyzed 199 participants 51 participants
37.2 27.5
Grade 3 Headache; Post-Inj. 1 Number Analyzed 199 participants 51 participants
1.5 0.0
Malaise; Post-Inj. 1 Number Analyzed 198 participants 51 participants
36.4 29.4
Grade 3 Malaise; Post-Inj. 1 Number Analyzed 198 participants 51 participants
2.5 0.0
Myalgia; Post-Inj. 1 Number Analyzed 198 participants 51 participants
22.7 23.5
Grade 3 Myalgia; Post-Inj. 1 Number Analyzed 198 participants 51 participants
2.0 0.0
Asthenia; Post-Inj. 2 Number Analyzed 197 participants 50 participants
23.9 6.0
Grade 3 Asthenia; Post-Inj. 2 Number Analyzed 197 participants 50 participants
0.5 0.0
Fever; Post-Inj. 2 Number Analyzed 197 participants 49 participants
15.2 10.2
Grade 3 Fever; Post-Inj. 2 Number Analyzed 197 participants 49 participants
2.5 0.0
Headache; Post-Inj. 2 Number Analyzed 197 participants 50 participants
31.0 16.0
Grade 3 Headache; Post-Inj. 2 Number Analyzed 197 participants 50 participants
0.5 2.0
Malaise; Post-Inj. 2 Number Analyzed 197 participants 50 participants
27.9 6.0
Grade 3 Malaise; Post-Inj. 2 Number Analyzed 197 participants 50 participants
0.5 0.0
Myalgia; Post-Inj. 2 Number Analyzed 197 participants 50 participants
18.8 8.0
Grade 3 Myalgia; Post-Inj. 2 Number Analyzed 197 participants 50 participants
0.5 0.0
Asthenia; Post-Inj. 3 Number Analyzed 195 participants 50 participants
19.0 12.0
Grade 3 Asthenia; Post-Inj. 3 Number Analyzed 195 participants 50 participants
1.5 0.0
Fever; Post-Inj. 3 Number Analyzed 190 participants 49 participants
9.5 2.0
Grade 3 Fever; Post-Inj. 3 Number Analyzed 190 participants 49 participants
3.7 0.0
Headache; Post-Inj. 3 Number Analyzed 195 participants 50 participants
22.6 14.0
Grade 3 Headache; Post-Inj. 3 Number Analyzed 195 participants 50 participants
1.5 0.0
Malaise; Post-Inj. 3 Number Analyzed 195 participants 50 participants
20.5 12.0
Grade 3 Malaise; Post-Inj. 3 Number Analyzed 195 participants 50 participants
1.5 0.0
Myalgia; Post-Inj. 3 Number Analyzed 195 participants 50 participants
17.4 10.0
Grade 3 Myalgia; Post-Inj. 3 Number Analyzed 195 participants 50 participants
1.0 0.0
2.Primary Outcome
Title Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Hide Description Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype with parental dengue virus strains (serotype 1, 2, 3, and 4) in the baseline sample.
Time Frame Day 0 up to Day 14 post-each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety analysis set. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 111 31
Measure Type: Number
Unit of Measure: Percentage of participants
Injection site Pain; Post-Injection 1 Number Analyzed 110 participants 31 participants
44.5 29.0
Injection site Erythema; Post-Injection 1 Number Analyzed 110 participants 31 participants
14.5 29.0
Injection site Swelling; Post-Injection 1 Number Analyzed 110 participants 31 participants
13.6 22.6
Asthenia; Post-Injection 1 Number Analyzed 111 participants 31 participants
27.9 25.8
Fever; Post-Injection 1 Number Analyzed 110 participants 30 participants
12.7 13.3
Malaise; Post-Injection 1 Number Analyzed 110 participants 31 participants
38.2 38.7
Myalgia; Post-Injection 1 Number Analyzed 110 participants 31 participants
22.7 25.8
Headache; Post-Injection 1 Number Analyzed 111 participants 31 participants
36.9 29.0
Injection site Pain; Post-Injection 2 Number Analyzed 110 participants 31 participants
48.2 32.3
Injection site Erythema; Post-Injection 2 Number Analyzed 110 participants 31 participants
25.5 29.0
Injection site Swelling; Post-Injection 2 Number Analyzed 110 participants 31 participants
9.1 16.1
Asthenia; Post-Injection 2 Number Analyzed 110 participants 31 participants
21.8 9.7
Fever; Post-Injection 2 Number Analyzed 110 participants 31 participants
18.2 9.7
Malaise; Post-Injection 2 Number Analyzed 110 participants 31 participants
29.1 3.2
Myalgia; Post-Injection 2 Number Analyzed 110 participants 31 participants
19.1 12.9
Headache; Post-Injection 2 Number Analyzed 110 participants 31 participants
31.8 12.9
Injection site Pain; Post-Injection 3 Number Analyzed 108 participants 31 participants
34.3 41.9
Injection site Erythema; Post-Injection 3 Number Analyzed 108 participants 31 participants
21.3 22.6
Injection site Swelling; Post-Injection 3 Number Analyzed 108 participants 31 participants
15.7 22.6
Asthenia; Post-Injection 3 Number Analyzed 108 participants 31 participants
13.9 16.1
Fever; Post-Injection 3 Number Analyzed 105 participants 30 participants
10.5 0.0
Malaise; Post-Injection 3 Number Analyzed 108 participants 31 participants
18.5 16.1
Myalgia; Post-Injection 3 Number Analyzed 108 participants 31 participants
14.8 16.1
Headache; Post-Injection 3 Number Analyzed 108 participants 31 participants
19.4 19.4
3.Primary Outcome
Title Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Hide Description Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Flavivirus-Naive participants were defined as participants without quantified antibodies against Japanese encephalitis and without antibody quantified against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
Time Frame Day 0 up to Day 14 post-each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety analysis set. Here, ''overall number of participants analyzed” signifies participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 88 20
Measure Type: Number
Unit of Measure: Percentage of participants
Injection site Pain; Post-Injection 1 Number Analyzed 88 participants 20 participants
37.5 25.0
Injection site Erythema; Post-Injection 1 Number Analyzed 88 participants 20 participants
31.8 15.0
Injection site Swelling; Post-Injection 1 Number Analyzed 88 participants 20 participants
25.0 20.0
Asthenia; Post-Injection 1 Number Analyzed 88 participants 20 participants
28.4 10.0
Fever; Post-Injection 1 Number Analyzed 88 participants 19 participants
12.5 0.0
Malaise; Post-Injection 1 Number Analyzed 88 participants 20 participants
34.1 15.0
Myalgia; Post-Injection 1 Number Analyzed 88 participants 20 participants
22.7 20.0
Headache; Post-Injection 1 Number Analyzed 88 participants 20 participants
37.5 25.0
Injection site Pain; Post-Injection 2 Number Analyzed 87 participants 19 participants
48.3 15.8
Injection site Erythema; Post-Injection 2 Number Analyzed 87 participants 19 participants
42.5 36.8
Injection site Swelling; Post-Injection 2 Number Analyzed 87 participants 19 participants
23.0 0.0
Asthenia; Post-Injection 2 Number Analyzed 87 participants 19 participants
26.4 0.0
Fever; Post-Injection 2 Number Analyzed 87 participants 18 participants
11.5 11.1
Malaise; Post-Injection 2 Number Analyzed 87 participants 19 participants
26.4 10.5
Myalgia; Post-Injection 2 Number Analyzed 87 participants 19 participants
18.4 0.0
Headache; Post-Injection 2 Number Analyzed 87 participants 19 participants
29.9 21.1
Injection site Pain; Post-Injection 3 Number Analyzed 87 participants 19 participants
47.1 31.6
Injection site Erythema; Post-Injection 3 Number Analyzed 87 participants 19 participants
26.4 26.3
Injection site Swelling; Post-Injection 3 Number Analyzed 87 participants 19 participants
25.3 26.3
Asthenia; Post-Injection 3 Number Analyzed 87 participants 19 participants
25.3 5.3
Fever; Post-Injection 3 Number Analyzed 85 participants 19 participants
8.2 5.3
Malaise; Post-Injection 3 Number Analyzed 87 participants 19 participants
23.0 5.3
Myalgia; Post-Injection 3 Number Analyzed 87 participants 19 participants
20.7 0.0
Headache; Post-Injection 3 Number Analyzed 87 participants 19 participants
26.4 5.3
4.Primary Outcome
Title Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Hide Description Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each dengue serotype (1,2, 3 and 4) and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Time Frame Pre-Injection 1 and Post-Injections 2 and 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 placebo and had at least one valid post-injection serology result. Here, ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 196 50
Measure Type: Number
Unit of Measure: Percentage of participants
Serotype 1; Pre-Injection 1 Number Analyzed 196 participants 50 participants
31.1 32.0
Serotype 1; Post-Injection 2 Number Analyzed 196 participants 50 participants
90.3 34.0
Serotype 1; Post-Injection 3 Number Analyzed 196 participants 50 participants
96.4 30.0
Serotype 2; Pre-Injection 1 Number Analyzed 196 participants 50 participants
27.6 30.0
Serotype 2; Post-Injection 2 Number Analyzed 196 participants 50 participants
94.9 34.0
Serotype 2; Post-Injection 3 Number Analyzed 196 participants 50 participants
96.9 34.0
Serotype 3; Pre-Injection 1 Number Analyzed 196 participants 49 participants
36.7 36.7
Serotype 3; Post-Injection 2 Number Analyzed 196 participants 50 participants
98.5 32.0
Serotype 3; Post-Injection 3 Number Analyzed 196 participants 50 participants
99.0 34.0
Serotype 4; Pre-Injection 1 Number Analyzed 196 participants 50 participants
24.0 30.0
Serotype 4; Post-Injection 2 Number Analyzed 196 participants 50 participants
91.8 32.0
Serotype 4; Post-Injection 3 Number Analyzed 196 participants 50 participants
98.0 28.0
5.Primary Outcome
Title Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Hide Description Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each dengue serotype (1, 2, 3, and 4) and was assessed using the dengue PRNT.
Time Frame Pre-Injection 1 and Post-Injections 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 196 50
Measure Type: Number
Unit of Measure: Percentage of participants
At least 1 serotype; Pre-Injection 1 44.9 48.0
At least 1 serotype; Post-Injection 2 100.0 46.0
At least 1 serotype; Post-Injection 3 100.0 42.0
At least 2 serotypes; Pre-Injection 1 29.1 28.0
At least 2 serotypes; Post-Injection 2 99.0 34.0
At least 2 serotypes; Post-Injection 3 100.0 32.0
At least 3 serotypes; Pre-Injection 1 25.5 28.0
At least 3 serotypes; Post-Injection 2 96.4 28.0
At least 3 serotypes; Post-Injection 3 98.5 30.0
All 4 serotypes; Pre-Injection 1 19.9 24.0
All 4 serotypes; Post-Injection 2 80.1 24.0
All 4 serotypes; Post-Injection 3 91.8 22.0
6.Primary Outcome
Title Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Hide Description GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the dengue PRNT.
Time Frame Pre-Injection 1 and Post-Injections 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 Placebo Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 196 50
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Serotype 1; Pre-Injection 1 Number Analyzed 196 participants 50 participants
15.3
(11.5 to 20.4)
18.6
(9.69 to 35.8)
Serotype 1; Post-Injection 2 Number Analyzed 196 participants 50 participants
119
(90.7 to 155)
21.0
(10.6 to 41.9)
Serotype 1; Post-Injection 3 Number Analyzed 196 participants 50 participants
151
(121 to 188)
18.9
(9.94 to 35.8)
Serotype 2; Pre-Injection 1 Number Analyzed 196 participants 50 participants
15.9
(11.8 to 21.3)
18.6
(10.0 to 34.5)
Serotype 2; Post-Injection 2 Number Analyzed 196 participants 50 participants
160
(127 to 203)
17.9
(9.91 to 32.2)
Serotype 2; Post-Injection 3 Number Analyzed 196 participants 50 participants
180
(146 to 221)
16.3
(9.59 to 27.7)
Serotype 3; Pre-Injection 1 Number Analyzed 196 participants 49 participants
15.6
(12.3 to 19.9)
15.9
(9.57 to 26.5)
Serotype 3; Post-Injection 2 Number Analyzed 196 participants 50 participants
196
(163 to 235)
15.9
(9.27 to 27.4)
Serotype 3; Post-Injection 3 Number Analyzed 196 participants 50 participants
193
(161 to 231)
16.3
(9.81 to 27.0)
Serotype 4; Pre-Injection 1 Number Analyzed 196 participants 50 participants
9.92
(8.17 to 12.0)
12.3
(7.96 to 19.0)
Serotype 4; Post-Injection 2 Number Analyzed 196 participants 50 participants
110
(88.9 to 136)
13.3
(7.94 to 22.1)
Serotype 4; Post-Injection 3 Number Analyzed 196 participants 50 participants
114
(97.0 to 134)
10.9
(7.34 to 16.2)
7.Primary Outcome
Title Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants
Hide Description Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each serotype (1, 2, 3, and 4) and was assessed using the Dengue PRNT. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
Time Frame Pre-Injection 1 and Post-Injections 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 109 31
Measure Type: Number
Unit of Measure: Percentage of participants
Serotype 1; Pre-Injection 1 Number Analyzed 109 participants 31 participants
56.0 51.6
Serotype 1; Post-Injection 2 Number Analyzed 109 participants 31 participants
96.3 48.4
Serotype 1; Post-Injection 3 Number Analyzed 109 participants 31 participants
97.2 41.9
Serotype 2; Pre-Injection 1 Number Analyzed 109 participants 31 participants
49.5 48.4
Serotype 2; Post-Injection 2 Number Analyzed 109 participants 31 participants
96.3 54.8
Serotype 2; Post-Injection 3 Number Analyzed 109 participants 31 participants
97.2 48.4
Serotype 3; Pre-Injection 1 Number Analyzed 109 participants 30 participants
66.1 60.0
Serotype 3; Post-Injection 2 Number Analyzed 109 participants 31 participants
100.0 51.6
Serotype 3; Post-Injection 3 Number Analyzed 109 participants 31 participants
99.1 48.4
Serotype 4; Pre-Injection 1 Number Analyzed 109 participants 31 participants
43.1 48.4
Serotype 4; Post-Injection 2 Number Analyzed 109 participants 31 participants
97.2 45.2
Serotype 4; Post-Injection 3 Number Analyzed 109 participants 31 participants
100.0 41.9
8.Primary Outcome
Title Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants
Hide Description Seropositivity was defined as participants achieving neutralizing antibody titers >=10 (1/dilution) against each serotype (1, 2, 3, and 4) and was assessed using the Dengue PRNT. Flavivirus naïve participants were defined as participants without quantified antibodies against Japanese encephalitis and without quantified antibodies against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
Time Frame Pre-Injection 1 and Post-Injections 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 87 19
Measure Type: Number
Unit of Measure: Percentage of participants
Serotype 1; Pre-Injection 1 0.0 0.0
Serotype 1; Post-Injection 2 82.8 10.5
Serotype 1; Post-Injection 3 95.4 10.5
Serotype 2; Pre-Injection 1 0.0 0.0
Serotype 2; Post-Injection 2 93.1 0.0
Serotype 2; Post-Injection 3 96.6 10.5
Serotype 3; Pre-Injection 1 0.0 0.0
Serotype 3; Post-Injection 2 96.6 0.0
Serotype 3; Post-Injection 3 98.9 10.5
Serotype 4; Pre-Injection 1 0.0 0.0
Serotype 4; Post-Injection 2 85.1 10.5
Serotype 4; Post-Injection 3 95.4 5.3
9.Primary Outcome
Title GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Hide Description GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the Dengue PRNT. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
Time Frame Pre-Injection 1 and Post-Injections 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 109 31
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Serotype 1; Pre-Injection 1 Number Analyzed 109 participants 31 participants
37.5
(24.0 to 58.6)
41.7
(16.0 to 109)
Serotype 1; Post-Injection 2 Number Analyzed 109 participants 31 participants
248
(171 to 361)
45.4
(16.3 to 127)
Serotype 1; Post-Injection 3 Number Analyzed 109 participants 31 participants
247
(178 to 343)
33.5
(13.3 to 84.4)
Serotype 2; Pre-Injection 1 Number Analyzed 109 participants 31 participants
39.9
(25.2 to 63.1)
41.6
(17.0 to 102)
Serotype 2; Post-Injection 2 Number Analyzed 109 participants 31 participants
306
(221 to 424)
39.0
(16.7 to 91.3)
Serotype 2; Post-Injection 3 Number Analyzed 109 participants 31 participants
292
(217 to 395)
30.0
(13.8 to 64.9)
Serotype 3; Pre-Injection 1 Number Analyzed 109 participants 30 participants
38.8
(27.3 to 55.4)
33.2
(16.1 to 68.5)
Serotype 3; Post-Injection 2 Number Analyzed 109 participants 31 participants
296
(230 to 381)
32.4
(14.8 to 71.0)
Serotype 3; Post-Injection 3 Number Analyzed 109 participants 31 participants
287
(219 to 376)
29.5
(14.2 to 61.1)
Serotype 4; Pre-Injection 1 Number Analyzed 109 participants 31 participants
17.1
(12.5 to 23.5)
21.3
(11.3 to 40.1)
Serotype 4; Post-Injection 2 Number Analyzed 109 participants 31 participants
152
(115 to 201)
21.7
(10.0 to 46.9)
Serotype 4; Post-Injection 3 Number Analyzed 109 participants 31 participants
155
(125 to 191)
16.5
(9.17 to 29.7)
10.Primary Outcome
Title GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Hide Description GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the Dengue PRNT. Flavivirus-Naive participants were defined as participants without quantified antibodies against Japanese encephalitis and without antibody quantified against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
Time Frame Pre-Injection 1 and Post- Injections 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 87 19
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Serotype 1; Pre-Injection 1
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Serotype 1; Post-Injection 2
47.1
(35.3 to 62.9)
5.98
(4.62 to 7.74)
Serotype 1; Post-Injection 3
81.6
(66.3 to 101)
7.38
(3.88 to 14.0)
Serotype 2; Pre-Injection 1
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Serotype 2; Post-Injection 2
71.4
(55.4 to 92.1)
5.00
(5.00 to 5.00)
Serotype 2; Post-Injection 3
97.5
(77.5 to 123)
6.03
(4.43 to 8.21)
Serotype 3; Pre-Injection 1
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Serotype 3; Post-Injection 2
116
(92.6 to 146)
5.00
(5.00 to 5.00)
Serotype 3; Post-Injection 3
117
(97.4 to 141)
6.17
(4.52 to 8.41)
Serotype 4; Pre-Injection 1
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Serotype 4; Post-Injection 2
73.3
(53.7 to 100)
5.95
(4.47 to 7.91)
Serotype 4; Post-Injection 3
78.0
(62.0 to 98.1)
5.54
(4.47 to 6.87)
Time Frame Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Adverse Event Reporting Description Analysis was performed on Safety analysis set.
 
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
All-Cause Mortality
CYD Dengue Vaccine Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/199 (0.00%)      0/51 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
CYD Dengue Vaccine Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/199 (5.53%)      7/51 (13.73%)    
Congenital, familial and genetic disorders     
Fibrous dysplasia of bone * 1  0/199 (0.00%)  0 1/51 (1.96%)  1
Gastrointestinal disorders     
Abdominal pain * 1  1/199 (0.50%)  1 0/51 (0.00%)  0
Infections and infestations     
Acute tonsillitis * 1  1/199 (0.50%)  1 0/51 (0.00%)  0
Enterocolitis infectious * 1  1/199 (0.50%)  1 0/51 (0.00%)  0
Gastroenteritis rotavirus * 1  2/199 (1.01%)  2 0/51 (0.00%)  0
Gastroenteritis viral * 1  0/199 (0.00%)  0 1/51 (1.96%)  1
Lobar pneumonia * 1  1/199 (0.50%)  1 0/51 (0.00%)  0
Pharyngotonsillitis * 1  1/199 (0.50%)  1 0/51 (0.00%)  0
Pneumonia * 1  1/199 (0.50%)  1 1/51 (1.96%)  1
Scarlet fever * 1  1/199 (0.50%)  1 0/51 (0.00%)  0
Viral infection * 1  1/199 (0.50%)  1 0/51 (0.00%)  0
Viral pharyngitis * 1  1/199 (0.50%)  1 1/51 (1.96%)  1
Injury, poisoning and procedural complications     
Overdose * 1  1/199 (0.50%)  1 0/51 (0.00%)  0
Skull fractured base * 1  0/199 (0.00%)  0 1/51 (1.96%)  1
Nervous system disorders     
Febrile convulsion * 1  1/199 (0.50%)  1 0/51 (0.00%)  0
VIIth nerve paralysis * 1  0/199 (0.00%)  0 1/51 (1.96%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  1/199 (0.50%)  1 2/51 (3.92%)  3
1
Term from vocabulary, MedDRA 13.0
*
Indicates events were collected by non-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 Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   138/199 (69.35%)      29/51 (56.86%)    
Gastrointestinal disorders     
Vomiting * 1  7/199 (3.52%)  7 3/51 (5.88%)  3
General disorders     
Pyrexia * 1  14/199 (7.04%)  14 1/51 (1.96%)  1
Injection site Pain; Post-Any  1  138/199 (69.35%)  138 29/51 (56.86%)  29
Injection site Erythema; Post-Any  1  93/199 (46.73%)  93 25/51 (49.02%)  25
Injection site Swelling; Post-Any  1  77/199 (38.69%)  77 18/51 (35.29%)  18
Asthenia; Post-Any Injection  1  94/199 (47.24%)  94 17/51 (33.33%)  17
Fever; Post-Any Injection  1  58/198 (29.29%)  58 10/51 (19.61%)  10
Malaise; Post-Any Injection  1  108/199 (54.27%)  108 21/51 (41.18%)  21
Infections and infestations     
Upper respiratory tract infection * 1  50/199 (25.13%)  61 11/51 (21.57%)  15
Musculoskeletal and connective tissue disorders     
Myalgia; Post-Any Injection  1  75/199 (37.69%)  75 16/51 (31.37%)  16
Nervous system disorders     
Headache; Post-Any Injection  1  104/199 (52.26%)  104 20/51 (39.22%)  20
Respiratory, thoracic and mediastinal disorders     
Cough * 1  24/199 (12.06%)  27 1/51 (1.96%)  1
1
Term from vocabulary, MedDRA 13.0
*
Indicates events were collected by non-systematic assessment
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: Director
Organization: Sanofi Pasteur SA
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01254422     History of Changes
Other Study ID Numbers: CYD32
UTN: U1111-1115-6579 ( Other Identifier: WHO )
First Submitted: December 3, 2010
First Posted: December 6, 2010
Results First Submitted: May 23, 2019
Results First Posted: July 29, 2019
Last Update Posted: July 29, 2019