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Trial record 50 of 1403 for:    Peru

Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years

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: NCT00788151
Recruitment Status : Completed
First Posted : November 10, 2008
Results First Posted : July 29, 2019
Last Update Posted : August 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Dengue Virus
Dengue Fever
Dengue Hemorrhagic Fever
Dengue Diseases
Interventions Biological: CYD Dengue Vaccine Serotypes 1, 2, 3, and 4
Biological: Pneumococcal polysaccharide vaccine
Enrollment 300
Recruitment Details Study participants were enrolled from 26 September 2008 to 16 August 2010 at 1 clinical site in Peru.
Pre-assignment Details A total of 300 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized in the study. Two participants were not vaccinated and were excluded from the Full analysis set and Safety analysis set.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). Participants received two injections of placebo, and 1 injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Period Title: Overall Study
Started 200 100
Received Vaccination 1 199 99
Received Vaccination 2 188 92
Received Vaccination 3 186 90
Completed 186 90
Not Completed 14 10
Reason Not Completed
Other adverse event             0             2
Protocol Violation             0             1
Withdrawal by Subject             13             6
Enrolled but not treated             1             1
Arm/Group Title CYD Dengue Vaccine Group Control Group Total
Hide Arm/Group Description Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). Participants received two injections of placebo, and 1 injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months). Total of all reporting groups
Overall Number of Baseline Participants 199 99 298
Hide Baseline Analysis Population Description
Analysis was performed in Full analysis set which included all the participants present at vaccination 1 and received at least 1 dose of vaccine.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 199 participants 99 participants 298 participants
6.4  (2.8) 6.4  (2.9) 6.4  (2.9)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 199 participants 99 participants 298 participants
2 to 5 years
100
  50.3%
50
  50.5%
150
  50.3%
6 to 11 years
99
  49.7%
49
  49.5%
148
  49.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 199 participants 99 participants 298 participants
Female
98
  49.2%
53
  53.5%
151
  50.7%
Male
101
  50.8%
46
  46.5%
147
  49.3%
1.Primary Outcome
Title Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Hide Description Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Time Frame Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety analysis set which included all participants who received at least 1 dose of dengue or control vaccine. Here, ‘number analyzed’ = participants with available data for specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Overall Number of Participants Analyzed 199 99
Measure Type: Number
Unit of Measure: Percentage of participants
Inj. site Pain; Post-Inj. 1 (2-11 years) Number Analyzed 199 participants 99 participants
20.6 17.2
Grade 3 Inj. site Pain; Post-Inj. 1 (2-11 years) Number Analyzed 199 participants 99 participants
0.0 0.0
Inj. site Erythema; Post-Inj. 1 (2-11 years) Number Analyzed 199 participants 99 participants
7.5 4.0
Grade 3 Inj. site Erythema;Post-Inj.1 (2-11 years) Number Analyzed 199 participants 99 participants
0.0 0.0
Inj. site Swelling; Post-Inj. 1 (2-11 years) Number Analyzed 199 participants 99 participants
5.5 5.1
Grade 3 Inj. site Swelling; Post-Inj.1(2-11 years) Number Analyzed 199 participants 99 participants
0.0 0.0
Inj. site Pain; Post-Inj. 2 (2-11 years) Number Analyzed 188 participants 92 participants
19.7 17.4
Grade 3 Inj. site Pain; Post-Inj. 2 (2-11 years) Number Analyzed 188 participants 92 participants
0.0 1.1
Inj. site Erythema; Post-Inj. 2 (2-11 years) Number Analyzed 188 participants 92 participants
4.3 1.1
Grade 3 Inj. site Erythema;Post-Inj.2 (2-11 years) Number Analyzed 188 participants 92 participants
0.0 0.0
Inj. site Swelling; Post-Inj. 2 (2-11 years) Number Analyzed 188 participants 92 participants
2.1 0.0
Grade 3 Inj. site Swelling;Post-Inj.2 (2-11 years) Number Analyzed 188 participants 92 participants
0.0 0.0
Inj. site Pain; Post-Inj. 3 (2-11 years) Number Analyzed 186 participants 90 participants
17.7 32.2
Grade 3 Inj. site Pain; Post-Inj. 3 (2-11 years) Number Analyzed 186 participants 90 participants
0.5 2.2
Inj. site Erythema; Post-Inj. 3 (2-11 years) Number Analyzed 186 participants 90 participants
4.3 11.1
Grade 3 Inj. site Erythema;Post-Inj.3 (2-11 years) Number Analyzed 186 participants 90 participants
0.0 3.3
Inj. site Swelling; Post-Inj. 3 (2-11 years) Number Analyzed 186 participants 90 participants
3.2 8.9
Grade 3 Inj. site Swelling;Post-Inj.3 (2-11 years) Number Analyzed 186 participants 90 participants
0.0 3.3
Fever; Post-Inj. 1 (2-11 years) Number Analyzed 198 participants 99 participants
31.3 10.1
Grade 3 Fever; Post-Inj. 1 (2-11 years) Number Analyzed 198 participants 99 participants
3.5 0.0
Headache; Post-Inj. 1 (2-11 years) Number Analyzed 199 participants 99 participants
35.7 16.2
Grade 3 Headache; Post-Inj. 1 (2-11 years) Number Analyzed 199 participants 99 participants
0.5 0.0
Malaise; Post-Inj. 1 (2-11 years) Number Analyzed 199 participants 99 participants
33.7 23.2
Grade 3 Malaise; Post-Inj. 1 (2-11 years) Number Analyzed 199 participants 99 participants
0.5 0.0
Myalgia; Post-Inj. 1 (2-11 years) Number Analyzed 199 participants 99 participants
19.1 13.1
Grade 3 Myalgia; Post-Inj. 1 (2-11 years) Number Analyzed 199 participants 99 participants
0.0 0.0
Asthenia; Post-Inj. 1 (2-11 years) Number Analyzed 199 participants 99 participants
13.6 13.1
Grade 3 Asthenia; Post-Inj. 1 (2-11 years) Number Analyzed 199 participants 99 participants
0.5 0.0
Fever; Post-Inj. 2 (2-11 years) Number Analyzed 188 participants 92 participants
19.7 16.3
Grade 3 Fever; Post-Inj. 2 (2-11 years) Number Analyzed 188 participants 92 participants
0.5 0.0
Headache; Post-Inj. 2 (2-11 years) Number Analyzed 188 participants 92 participants
22.3 19.6
Grade 3 Headache; Post-Inj. 2 (2-11 years) Number Analyzed 188 participants 92 participants
0.5 1.1
Malaise; Post-Inj. 2 (2-11 years) Number Analyzed 188 participants 92 participants
18.1 16.3
Grade 3 Malaise; Post-Inj. 2 (All ages) Number Analyzed 188 participants 92 participants
0.5 2.2
Myalgia; Post-Inj. 2 (2-11 years) Number Analyzed 188 participants 92 participants
14.9 10.9
Grade 3 Myalgia; Post-Inj. 2 (2-11 years) Number Analyzed 188 participants 92 participants
1.1 0.0
Asthenia; Post-Inj. 2 (2-11 years) Number Analyzed 188 participants 92 participants
11.2 7.6
Grade 3 Asthenia; Post-Inj. 2 (2-11 years) Number Analyzed 188 participants 92 participants
0.5 1.1
Fever; Post-Inj. 3 (2-11 years) Number Analyzed 185 participants 89 participants
18.4 22.5
Grade 3 Fever; Post-Inj. 3 (2-11 years) Number Analyzed 185 participants 89 participants
0.0 3.4
Headache; Post-Inj. 3 (2-11 years) Number Analyzed 186 participants 90 participants
18.8 27.8
Grade 3 Headache; Post-Inj. 3 (2-11 years) Number Analyzed 186 participants 90 participants
0.0 3.3
Malaise; Post-Inj. 3 (2-11 years) Number Analyzed 186 participants 90 participants
16.7 23.3
Grade 3 Malaise; Post-Inj. 3 (2-11 years) Number Analyzed 186 participants 90 participants
0.0 2.2
Myalgia; Post-Inj. 3 (2-11 years) Number Analyzed 186 participants 90 participants
13.4 26.7
Grade 3 Myalgia; Post-Inj. 3 (2-11 years) Number Analyzed 186 participants 90 participants
0.0 2.2
Asthenia; Post-Inj. 3 (2-11 years) Number Analyzed 186 participants 90 participants
10.2 16.7
Grade 3 Asthenia; Post-Inj. 3 (2-11 years) Number Analyzed 186 participants 90 participants
0.0 1.1
2.Primary Outcome
Title Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Hide Description Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Time Frame Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety analysis set. Here, “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Overall Number of Participants Analyzed 100 50
Measure Type: Number
Unit of Measure: Percentage of participants
Inj. site Pain: Post-Inj.1 (2-5 years) Number Analyzed 100 participants 50 participants
19.0 16.0
Grade 3 Inj. site Pain; Post-Inj. 1 (2-5 years) Number Analyzed 100 participants 50 participants
0.0 0.0
Inj. site Erythema; Post-Inj. 1 (2-5 years) Number Analyzed 100 participants 50 participants
11.0 6.0
Grade 3 Inj. site Erythema;Post-Inj. 1 (2-5 years) Number Analyzed 100 participants 50 participants
0.0 0.0
Inj. site Swelling; Post-Inj. 1 (2-5 years) Number Analyzed 100 participants 50 participants
6.0 8.0
Grade 3 Inj. site Swelling;Post-Inj. 1 (2-5 years) Number Analyzed 100 participants 50 participants
0.0 0.0
Inj. site Pain; Post-Inj. 2 (2-5 years) Number Analyzed 92 participants 45 participants
17.4 15.6
Grade 3 Inj. site Pain; Post-Inj. 2 (2-5 years) Number Analyzed 92 participants 45 participants
0.0 2.2
Inj. site Erythema; Post-Inj. 2 (2-5 years) Number Analyzed 92 participants 45 participants
4.3 0.0
Grade 3 Inj. site Erythema;Post-Inj. 2 (2-5 years) Number Analyzed 92 participants 45 participants
0.0 0.0
Inj. site Swelling; Post-Inj. 2 (2-5 years) Number Analyzed 92 participants 45 participants
2.2 0.0
Grade 3 Inj. site Swelling;Post-Inj. 2 (2-5 years) Number Analyzed 92 participants 45 participants
0.0 0.0
Inj. site Pain; Post-Inj. 3 (2-5 years) Number Analyzed 90 participants 43 participants
14.4 23.3
Grade 3 Inj. site Pain; Post-Inj. 3 (2-5 years) Number Analyzed 90 participants 43 participants
0.0 4.7
Inj. site Erythema; Post-Inj. 3 (2-5 years) Number Analyzed 90 participants 43 participants
3.3 9.3
Grade 3 Inj. site Erythema;Post-Inj. 3 (2-5 years Number Analyzed 90 participants 43 participants
0.0 2.3
Inj. site Swelling; Post-Inj. 3 (2-5 years) Number Analyzed 90 participants 43 participants
3.3 7.0
Grade 3 Inj. site Swelling;Post-Inj. 3 (2-5 years) Number Analyzed 90 participants 43 participants
0.0 2.3
Fever; Post-Inj. 1 (2-5 years) Number Analyzed 99 participants 50 participants
36.4 16.0
Grade 3 Fever; Post-Inj. 1 (2-5 years) Number Analyzed 99 participants 50 participants
4.0 0.0
Headache; Post-Inj. 1 (2-5 years) Number Analyzed 100 participants 50 participants
23.0 8.0
Grade 3 Headache; Post-Inj. 1 (2-5 years) Number Analyzed 100 participants 50 participants
1.0 0.0
Malaise; Post-Inj. 1 (2-5 years) Number Analyzed 100 participants 50 participants
33.0 26.0
Grade 3 Malaise; Post-Inj. 1 (2-5 years) Number Analyzed 100 participants 50 participants
1.0 0.0
Myalgia; Post-Inj. 1 (2-5 years) Number Analyzed 100 participants 50 participants
12.0 10.0
Grade 3 Myalgia; Post-Inj. 1 (2-5 years) Number Analyzed 100 participants 50 participants
0.0 0.0
Asthenia; Post-Inj. 1 (2-5 years) Number Analyzed 100 participants 50 participants
13.0 12.0
Grade 3 Asthenia; Post-Inj. 1 (2-5 years) Number Analyzed 100 participants 50 participants
1.0 0.0
Fever; Post-Inj. 2 (2-5 years) Number Analyzed 92 participants 45 participants
23.9 17.8
Grade 3 Fever; Post-Inj. 2 (2-5 years) Number Analyzed 92 participants 45 participants
0.0 0.0
Headache; Post-Inj. 2 (2-5 years) Number Analyzed 92 participants 45 participants
14.1 6.7
Grade 3 Headache; Post-Inj. 2 (2-5 years) Number Analyzed 92 participants 45 participants
0.0 0.0
Malaise; Post-Inj. 2 (2-5 years) Number Analyzed 92 participants 45 participants
15.2 13.3
Grade 3 Malaise; Post-Inj. 2 (2-5 years) Number Analyzed 92 participants 45 participants
1.1 2.2
Myalgia; Post-Inj. 2 (2-5 years) Number Analyzed 92 participants 45 participants
9.8 6.7
Grade 3 Myalgia; Post-Inj. 2 (2-5 years) Number Analyzed 92 participants 45 participants
1.1 0.0
Asthenia; Post-Inj. 2 (2-5 years) Number Analyzed 92 participants 45 participants
9.8 8.9
Grade 3 Asthenia; Post-Inj. 2 (2-5 years) Number Analyzed 92 participants 45 participants
1.1 2.2
Fever; Post-Inj. 3 (2-5 years) Number Analyzed 89 participants 42 participants
16.9 26.2
Grade 3 Fever; Post-Inj. 3 (2-5 years) Number Analyzed 89 participants 42 participants
0.0 7.1
Headache; Post-Inj. 3 (2-5 years) Number Analyzed 90 participants 43 participants
6.7 18.6
Grade 3 Headache; Post-Inj. 3 (2-5 years) Number Analyzed 90 participants 43 participants
0.0 2.3
Malaise; Post-Inj. 3 (2-5 years) Number Analyzed 90 participants 43 participants
6.7 23.3
Grade 3 Malaise; Post-Inj. 3 (2-5 years) Number Analyzed 90 participants 43 participants
0.0 2.3
Myalgia; Post-Inj. 3 (2-5 years) Number Analyzed 90 participants 43 participants
6.7 20.9
Grade 3 Myalgia; Post-Inj. 3 (2-5 years) Number Analyzed 90 participants 43 participants
0.0 2.3
Asthenia; Post-Inj. 3 (2-5 years) Number Analyzed 90 participants 43 participants
4.4 23.3
Grade 3 Asthenia; Post-Inj. 3 (2-5 years) Number Analyzed 90 participants 43 participants
0.0 2.3
3.Primary Outcome
Title Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Hide Description Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: >= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: > 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Time Frame Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety analysis set. Here, “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Overall Number of Participants Analyzed 99 49
Measure Type: Number
Unit of Measure: Percentage of participants
Inj. site Pain; Post-Inj.1 (6-11 years) Number Analyzed 99 participants 49 participants
22.2 18.4
Grade 3 Inj. site Pain; Post-Inj. 1 (6-11 years) Number Analyzed 99 participants 49 participants
0.0 0.0
Inj. site Erythema; Post-Inj. 1 (6-11 years) Number Analyzed 99 participants 49 participants
4.0 2.0
Grade 3 Inj. site Erythema; Post-Inj.1(6-11 years) Number Analyzed 99 participants 49 participants
0.0 0.0
Inj. site Swelling; Post-Inj. 1 (6-11 years) Number Analyzed 99 participants 49 participants
5.1 2.0
Grade 3 Inj. site Swelling; Post-Inj.1(6-11 years) Number Analyzed 99 participants 49 participants
0.0 0.0
Inj. site Pain; Post-Inj. 2 (6-11 years) Number Analyzed 96 participants 47 participants
21.9 19.1
Grade 3 Inj. site Pain; Post-Inj. 2 (6-11 years) Number Analyzed 96 participants 47 participants
0.0 0.0
Inj. site Erythema; Post-Inj. 2 (6-11 years) Number Analyzed 96 participants 47 participants
4.2 2.1
Grade 3 Inj. site Erythema; Post-Inj.2(6-11 years) Number Analyzed 96 participants 47 participants
0.0 0.0
Inj. site Swelling; Post-Inj. 2 (6-11 years) Number Analyzed 96 participants 47 participants
2.1 0.0
Grade 3 Inj. site Swelling; Post-Inj.2(6-11 years) Number Analyzed 96 participants 47 participants
0.0 0.0
Inj. site Pain; Post-Inj. 3 (6-11 years) Number Analyzed 96 participants 47 participants
20.8 40.4
Grade 3 Inj. site Pain; Post-Inj. 3 (6-11 years) Number Analyzed 96 participants 47 participants
1.0 0.0
Inj. site Erythema; Post-Inj. 3 (6-11 years) Number Analyzed 96 participants 47 participants
5.2 12.8
Grade 3 Inj. site Erythema; Post-Inj.3(6-11 years) Number Analyzed 96 participants 47 participants
0.0 4.3
Inj. site Swelling; Post-Inj. 3 (6-11 years) Number Analyzed 96 participants 47 participants
3.1 10.6
Grade 3 Inj. site Swelling; Post-Inj.3(6-11 years) Number Analyzed 96 participants 47 participants
0.0 4.3
Fever; Post-Inj. 1 (6-11 years) Number Analyzed 99 participants 49 participants
26.3 4.1
Grade 3 Fever; Post-Inj. 1 (6-11 years) Number Analyzed 99 participants 49 participants
3.0 0.0
Headache; Post-Inj. 1 (6-11 years) Number Analyzed 99 participants 49 participants
48.5 24.5
Grade 3 Headache; Post-Inj. 1 (6-11 years) Number Analyzed 99 participants 49 participants
0.0 0.0
Malaise; Post-Inj. 1 (6-11 years) Number Analyzed 99 participants 49 participants
34.3 20.4
Grade 3 Malaise; Post-Inj. 1 (6-11 years) Number Analyzed 99 participants 49 participants
0.0 0.0
Myalgia; Post-Inj. 1 (6-11 years) Number Analyzed 99 participants 49 participants
26.3 16.3
Grade 3 Myalgia; Post-Inj. 1 (6-11 years) Number Analyzed 99 participants 49 participants
0.0 0.0
Asthenia; Post-Inj. 1 (6-11 years) Number Analyzed 99 participants 49 participants
14.1 14.3
Grade 3 Asthenia; Post-Inj. 1 (6-11 years) Number Analyzed 99 participants 49 participants
0.0 0.0
Fever; Post-Inj. 2 (6-11 years) Number Analyzed 96 participants 47 participants
15.6 14.9
Grade 3 Fever; Post-Inj. 2 (6-11 years) Number Analyzed 96 participants 47 participants
1.0 0.0
Headache; Post-Inj. 2 (6-11 years) Number Analyzed 96 participants 47 participants
30.2 31.9
Grade 3 Headache; Post-Inj. 2 (6-11 years) Number Analyzed 96 participants 47 participants
1.0 2.1
Malaise; Post-Inj. 2 (6-11 years) Number Analyzed 96 participants 47 participants
20.8 19.1
Grade 3 Malaise; Post-Inj. 2 (6-11 years) Number Analyzed 96 participants 47 participants
0.0 2.1
Myalgia; Post-Inj. 2 (6-11 years) Number Analyzed 96 participants 47 participants
19.8 14.9
Grade 3 Myalgia; Post-Inj. 2 (6-11 years) Number Analyzed 96 participants 47 participants
1.0 0.0
Asthenia; Post-Inj. 2 (6-11 years) Number Analyzed 96 participants 47 participants
12.5 6.4
Grade 3 Asthenia; Post-Inj. 2 (6-11 years) Number Analyzed 96 participants 47 participants
0.0 0.0
Fever; Post-Inj. 3 (6-11 years) Number Analyzed 96 participants 47 participants
19.8 19.1
Grade 3 Fever; Post-Inj. 3 (6-11 years) Number Analyzed 96 participants 47 participants
0.0 0.0
Headache; Post-Inj. 3 (6-11 years) Number Analyzed 96 participants 47 participants
30.2 36.2
Grade 3 Headache; Post-Inj. 3 (6-11 years) Number Analyzed 96 participants 47 participants
0.0 4.3
Malaise; Post-Inj. 3 (6-11 years) Number Analyzed 96 participants 47 participants
26.0 23.4
Grade 3 Malaise; Post-Inj. 3 (6-11 years) Number Analyzed 96 participants 47 participants
0.0 2.1
Myalgia; Post-Inj. 3 (6-11 years) Number Analyzed 96 participants 47 participants
19.8 31.9
Grade 3 Myalgia; Post-Inj. 3 (6-11 years) Number Analyzed 96 participants 47 participants
0.0 2.1
Asthenia; Post-Inj. 3 (6-11 years) Number Analyzed 96 participants 47 participants
15.6 10.6
Grade 3 Asthenia; Post-Inj. 3 (6-11 years) Number Analyzed 96 participants 47 participants
0.0 0.0
4.Secondary Outcome
Title Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.
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 which included all the participants present at visit 1 and who received at least one dose of vaccine. Here, 'number analyzed' = participants with available data for specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Overall Number of Participants Analyzed 199 99
Measure Type: Number
Unit of Measure: Percentage of participants
Dengue parental serotype 1; Pre-Inj. 1 Number Analyzed 199 participants 99 participants
29.6 38.4
Dengue parental serotype 1; 28 days Post-Inj. 1 Number Analyzed 193 participants 95 participants
55.4 37.9
Dengue parental serotype 1; Pre-Inj. 2 Number Analyzed 189 participants 92 participants
42.3 39.1
Dengue parental serotype 1; 28 days Post-Inj. 2 Number Analyzed 188 participants 92 participants
98.4 39.1
Dengue parental serotype 1; Pre-Inj. 3 Number Analyzed 186 participants 91 participants
74.7 41.8
Dengue parental serotype 1; 28 days Post-Inj. 3 Number Analyzed 186 participants 89 participants
98.4 46.1
Dengue parental serotype 2; Pre-Inj. 1 Number Analyzed 199 participants 99 participants
17.1 21.2
Dengue parental serotype 2; 28 days Post-Inj. 1 Number Analyzed 193 participants 95 participants
40.4 21.1
Dengue parental serotype 2; Pre-Inj. 2 Number Analyzed 189 participants 93 participants
32.8 20.4
Dengue parental serotype 2; 28 days Post-Inj. 2 Number Analyzed 188 participants 92 participants
68.1 16.3
Dengue parental serotype 2; Pre-Inj. 3 Number Analyzed 186 participants 91 participants
35.5 20.9
Dengue parental serotype 2; 28 days Post-Inj. 3 Number Analyzed 186 participants 89 participants
79.0 20.2
Dengue parental serotype 3; Pre-Inj. 1 Number Analyzed 199 participants 99 participants
30.7 38.4
Dengue parental serotype 3; 28 days Post-Inj.1 Number Analyzed 193 participants 95 participants
68.4 38.9
Dengue parental serotype 3; Pre-Inj. 2 Number Analyzed 189 participants 93 participants
51.9 39.8
Dengue parental serotype 3; 28 days Post-Inj. 2 Number Analyzed 188 participants 92 participants
100.0 40.2
Dengue parental serotype 3; Pre-Inj. 3 Number Analyzed 186 participants 91 participants
72.6 39.6
Dengue parental serotype 3; 28 days Post-Inj. 3 Number Analyzed 186 participants 89 participants
98.9 43.8
Dengue parental serotype 4; Pre-Inj. 1 Number Analyzed 199 participants 99 participants
14.1 18.2
Dengue parental serotype 4; 28 days Post-Inj. 1 Number Analyzed 193 participants 95 participants
74.1 18.9
Dengue parental serotype 4; Pre-Inj. 2 Number Analyzed 189 participants 93 participants
57.7 20.4
Dengue parental serotype 4; 28 days Post-Inj. 2 Number Analyzed 188 participants 92 participants
97.9 19.6
Dengue parental serotype 4; Pre-Inj. 3 Number Analyzed 186 participants 91 participants
82.8 18.7
Dengue parental serotype 4; 28 days Post-Inj. 3 Number Analyzed 186 participants 89 participants
98.9 23.6
5.Secondary Outcome
Title Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.
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” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Overall Number of Participants Analyzed 100 50
Measure Type: Number
Unit of Measure: Percentage of participants
Dengue parental serotype 1; Pre-Inj. 1 Number Analyzed 100 participants 50 participants
30.0 32.0
Dengue parental serotype 1; 28 days Post-Inj. 1 Number Analyzed 95 participants 48 participants
54.7 33.3
Dengue parental serotype 1; Pre-Inj. 2 Number Analyzed 93 participants 45 participants
38.7 31.1
Dengue parental serotype 1; 28 days Post-Inj. 2 Number Analyzed 92 participants 45 participants
97.8 31.1
Dengue parental serotype 1; Pre-Inj. 3 Number Analyzed 90 participants 44 participants
72.2 36.4
Dengue parental serotype 1; 28 days Post-Inj. 3 Number Analyzed 90 participants 43 participants
98.9 44.2
Dengue parental serotype 2; Pre-Inj. 1 Number Analyzed 100 participants 50 participants
14.0 16.0
Dengue parental serotype 2; 28 days Post-Inj. 1 Number Analyzed 95 participants 48 participants
32.6 16.7
Dengue parental serotype 2; Pre-Inj. 2 Number Analyzed 93 participants 46 participants
29.0 15.2
Dengue parental serotype 2; 28 days Post-Inj. 2 Number Analyzed 92 participants 45 participants
64.1 11.1
Dengue parental serotype 2; Pre-Inj. 3 Number Analyzed 90 participants 44 participants
28.9 18.2
Dengue parental serotype 2; 28 days Post-Inj. 3 Number Analyzed 90 participants 43 participants
77.8 20.9
Dengue parental serotype 3; Pre-Inj. 1 Number Analyzed 100 participants 50 participants
28.0 32.0
Dengue parental serotype 3; 28 days Post-Inj. 1 Number Analyzed 95 participants 48 participants
62.1 35.4
Dengue parental serotype 3; Pre-Inj. 2 Number Analyzed 93 participants 46 participants
45.2 32.6
Dengue parental serotype 3; 28 days Post-Inj. 2 Number Analyzed 92 participants 45 participants
100.0 33.3
Dengue parental serotype 3; Pre-Inj. 3 Number Analyzed 90 participants 44 participants
70.0 34.1
Dengue parental serotype 3; 28 days Post-Inj. 3 Number Analyzed 90 participants 43 participants
100.0 39.5
Dengue parental serotype 4; Pre-Inj. 1 Number Analyzed 100 participants 50 participants
13.0 18.0
Dengue parental serotype 4; 28 days Post-Inj. 1 Number Analyzed 95 participants 48 participants
74.7 22.9
Dengue parental serotype 4; Pre-Inj. 2 Number Analyzed 93 participants 46 participants
60.2 17.4
Dengue parental serotype 4; 28 days Post-Inj. 2 Number Analyzed 92 participants 45 participants
100.0 20.0
Dengue parental serotype 4; Pre-Inj. 3 Number Analyzed 90 participants 44 participants
87.8 22.7
Dengue parental serotype 4; 28 days Post-Inj. 3 Number Analyzed 90 participants 43 participants
100.0 27.9
6.Secondary Outcome
Title Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.
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” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Overall Number of Participants Analyzed 99 49
Measure Type: Number
Unit of Measure: Percentage of participants
Dengue parental serotype 1; Pre-Inj. 1 Number Analyzed 99 participants 49 participants
29.3 44.9
Dengue parental serotype 1; 28 days Post-Inj. 1 Number Analyzed 98 participants 47 participants
56.1 42.6
Dengue parental serotype 1; Pre-Inj. 2 Number Analyzed 96 participants 47 participants
45.8 46.8
Dengue parental serotype 1; 28 days Post-Inj. 2 Number Analyzed 96 participants 47 participants
99.0 46.8
Dengue parental serotype 1; Pre-Inj. 3 Number Analyzed 96 participants 47 participants
77.1 46.8
Dengue parental serotype 1; 28 days Post-Inj. 3 Number Analyzed 96 participants 46 participants
97.9 47.8
Dengue parental serotype 2; Pre-Inj. 1 Number Analyzed 99 participants 49 participants
20.2 26.5
Dengue parental serotype 2; 28 days Post-Inj. 1 Number Analyzed 98 participants 47 participants
48.0 25.5
Dengue parental serotype 2; Pre-Inj. 2 Number Analyzed 96 participants 47 participants
36.5 25.5
Dengue parental serotype 2; 28 days Post-Inj. 2 Number Analyzed 96 participants 47 participants
71.9 21.3
Dengue parental serotype 2; Pre-Inj. 3 Number Analyzed 96 participants 47 participants
41.7 23.4
Dengue parental serotype 2; 28 days Post-Inj. 3 Number Analyzed 96 participants 46 participants
80.2 19.6
Dengue parental serotype 3; Pre-Inj. 1 Number Analyzed 99 participants 49 participants
33.3 44.9
Dengue parental serotype 3; 28 days Post-Inj 1 Number Analyzed 98 participants 47 participants
74.5 42.6
Dengue parental serotype 3; Pre-Inj. 2 Number Analyzed 96 participants 47 participants
58.3 46.8
Dengue parental serotype 3; 28 days Post-Inj. 2 Number Analyzed 96 participants 47 participants
100.0 46.8
Dengue parental serotype 3; Pre-Inj. 3 Number Analyzed 96 participants 47 participants
75.0 44.7
Dengue parental serotype 3; 28 days Post-Inj. 3 Number Analyzed 96 participants 46 participants
97.9 47.8
Dengue parental serotype 4; Pre-Inj. 1 Number Analyzed 99 participants 49 participants
15.2 18.4
Dengue parental serotype 4; 28 days Post-Inj. 1 Number Analyzed 98 participants 47 participants
73.5 14.9
Dengue parental serotype 4; Pre-Inj. 2 Number Analyzed 96 participants 47 participants
55.2 23.4
Dengue parental serotype 4; 28 days Post-Inj. 2 Number Analyzed 96 participants 47 participants
95.8 19.1
Dengue parental serotype 4; Pre-Inj. 3 Number Analyzed 96 participants 47 participants
78.1 14.9
Dengue parental serotype 4; 28 days Post-Inj. 3 Number Analyzed 96 participants 46 participants
97.9 19.6
7.Secondary Outcome
Title Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer >= 10 1/dilution.
Time Frame Pre-Injection 1 and 28 days Post-Injection 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 specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Overall Number of Participants Analyzed 199 99
Measure Type: Number
Unit of Measure: Percentage of participants
Dengue parental serotype 1; Pre-Inj. 1 Number Analyzed 196 participants 99 participants
30.6 36.4
Dengue parental serotype 1; 28 days Post-Inj. 2 Number Analyzed 187 participants 92 participants
94.7 39.1
Dengue parental serotype 1; 28 days Post-Inj. 3 Number Analyzed 186 participants 89 participants
96.2 48.3
Dengue parental serotype 2; Pre-Inj. 1 Number Analyzed 197 participants 99 participants
31.5 41.4
Dengue parental serotype 2; 28 days Post-Inj. 2 Number Analyzed 187 participants 92 participants
97.9 43.5
Dengue parental serotype 2; 28 days Post-Inj. 3 Number Analyzed 186 participants 89 participants
98.4 47.2
Dengue parental serotype 3; Pre-Inj. 1 Number Analyzed 197 participants 99 participants
35.0 46.5
Dengue parental serotype 3; 28 days Post-Inj. 2 Number Analyzed 187 participants 92 participants
98.9 51.1
Dengue parental serotype 3; 28 days Post-Inj. 3 Number Analyzed 186 participants 89 participants
98.4 67.4
Dengue parental serotype 4; Pre-Inj. 1 Number Analyzed 197 participants 99 participants
19.3 22.2
Dengue parental serotype 4; 28 days Post-Inj. 2 Number Analyzed 185 participants 92 participants
98.4 35.9
Dengue parental serotype 4; 28 days Post-Inj. 3 Number Analyzed 185 participants 89 participants
98.9 48.3
8.Secondary Outcome
Title Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.
Time Frame Pre-Injection 1 and 28 days Post-Injection 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 who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Overall Number of Participants Analyzed 100 50
Measure Type: Number
Unit of Measure: Percentage of participants
Dengue parental serotype 1; Pre-Inj. 1 Number Analyzed 99 participants 50 participants
30.3 30.0
Dengue parental serotype 1; 28 days Post-Inj. 2 Number Analyzed 92 participants 45 participants
96.7 31.1
Dengue parental serotype 1; 28 days Post-Inj. 3 Number Analyzed 90 participants 43 participants
97.8 41.9
Dengue parental serotype 2; Pre-Inj. 1 Number Analyzed 99 participants 50 participants
30.3 38.0
Dengue parental serotype 2; 28 days Post-Inj. 2 Number Analyzed 92 participants 45 participants
96.7 37.8
Dengue parental serotype 2; 28 days Post-Inj. 3 Number Analyzed 90 participants 43 participants
100.0 44.2
Dengue parental serotype 3; Pre-Inj. 1 Number Analyzed 99 participants 50 participants
35.4 38.0
Dengue parental serotype 3; 28 days Post-Inj. 2 Number Analyzed 92 participants 45 participants
98.9 53.3
Dengue parental serotype 3; 28 days Post-Inj. 3 Number Analyzed 90 participants 43 participants
98.9 65.1
Dengue parental serotype 4; Pre-Inj. 1 Number Analyzed 99 participants 50 participants
16.2 22.0
Dengue parental serotype 4; 28 days Post-Inj. 2 Number Analyzed 90 participants 45 participants
97.8 35.6
Dengue parental serotype 4; 28 days Post-Inj. 3 Number Analyzed 90 participants 43 participants
100.0 46.5
9.Secondary Outcome
Title Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.
Time Frame Pre-Injection 1 and 28 days Post-Injection 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 who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Overall Number of Participants Analyzed 99 49
Measure Type: Number
Unit of Measure: Percentage of participants
Dengue parental serotype 1; Pre-Inj. 1 Number Analyzed 97 participants 49 participants
30.9 42.9
Dengue parental serotype 1; 28 days Post-Inj. 2 Number Analyzed 95 participants 47 participants
92.6 46.8
Dengue parental serotype 1; 28 days Post-Inj. 3 Number Analyzed 96 participants 46 participants
94.8 54.3
Dengue parental serotype 2; Pre-Inj. 1 Number Analyzed 98 participants 49 participants
32.7 44.9
Dengue parental serotype 2; 28 days Post-Inj. 2 Number Analyzed 95 participants 47 participants
98.9 48.9
Dengue parental serotype 2; 28 days Post-Inj. 3 Number Analyzed 96 participants 46 participants
96.9 50.0
Dengue parental serotype 3; Pre-Inj. 1 Number Analyzed 98 participants 49 participants
34.7 55.1
Dengue parental serotype 3; 28 days Post-Inj. 2 Number Analyzed 95 participants 47 participants
98.9 48.9
Dengue parental serotype 3; 28 days Post-Inj. 3 Number Analyzed 96 participants 46 participants
97.9 69.6
Dengue parental serotype 4; Pre-Inj. 1 Number Analyzed 98 participants 49 participants
22.4 22.4
Dengue parental serotype 4; 28 days Post-Inj. 2 Number Analyzed 95 participants 47 participants
98.9 36.2
Dengue parental serotype 4; 28 days Post-Inj. 3 Number Analyzed 95 participants 46 participants
97.9 50.0
10.Secondary Outcome
Title Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.
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” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Overall Number of Participants Analyzed 199 99
Measure Type: Number
Unit of Measure: Percentage of participants
At least 1 positive serotype; Pre-Inj. 1 Number Analyzed 199 participants 99 participants
32.2 40.4
At least 1 positive serotype; 28 days Post-Inj. 1 Number Analyzed 193 participants 95 participants
80.8 40.0
At least 1 positive serotype; Pre-Inj. 2 Number Analyzed 189 participants 93 participants
69.8 40.9
At least 1 positive serotype; 28 days Post-Inj. 2 Number Analyzed 188 participants 92 participants
100.0 42.4
At least 1 positive serotype; Pre-Inj. 3 Number Analyzed 186 participants 91 participants
88.7 42.9
At least 1 positive serotype; 28 days Post-Inj. 3 Number Analyzed 186 participants 89 participants
98.9 48.3
At least 2 positive serotypes; Pre-Inj. 1 Number Analyzed 199 participants 99 participants
29.1 38.4
At least 2 positive serotypes; 28 days Post-Inj. 1 Number Analyzed 193 participants 95 participants
66.8 38.9
At least 2 positive serotypes; Pre-Inj. 2 Number Analyzed 189 participants 93 participants
49.2 39.8
At least 2 positive serotypes; 28 days Post-Inj. 2 Number Analyzed 188 participants 92 participants
100.0 40.2
At least 2 positive serotypes; Pre-Inj. 3 Number Analyzed 186 participants 91 participants
75.3 39.6
At least 2 positive serotypes; 28 days Post-Inj. 3 Number Analyzed 186 participants 89 participants
98.9 43.8
At least 3 positive serotypes; Pre-Inj. 1 Number Analyzed 199 participants 99 participants
19.6 24.2
At least 3 positive serotypes; 28 days Post-Inj. 1 Number Analyzed 193 participants 95 participants
52.8 25.3
At least 3 positive serotypes; Pre-Inj. 2 Number Analyzed 189 participants 93 participants
38.1 22.6
At least 3 positive serotypes; 28 days Post-Inj. 2 Number Analyzed 188 participants 92 participants
98.4 21.7
At least 3 positive serotypes; Pre-Inj. 3 Number Analyzed 186 participants 91 participants
67.7 25.3
At least 3 positive serotypes; 28 days Post-Inj. 3 Number Analyzed 186 participants 89 participants
98.4 25.8
All 4 positive serotypes; Pre-Inj. 1 Number Analyzed 199 participants 99 participants
10.6 13.1
All 4 positive serotypes; 28 days Post-Inj. 1 Number Analyzed 193 participants 95 participants
37.8 12.6
All 4 positive serotypes; Pre-Inj. 2 Number Analyzed 189 participants 93 participants
27.5 16.1
All 4 positive serotypes; 28 days Post-Inj. 2 Number Analyzed 188 participants 92 participants
66.0 10.9
All 4 positive serotypes; Pre-Inj. 3 Number Analyzed 186 participants 91 participants
33.9 13.2
All 4 positive serotypes; 28 days Post-Inj. 3 Number Analyzed 186 participants 89 participants
79.0 15.7
11.Secondary Outcome
Title Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >= 10 1/dilution.
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” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Overall Number of Participants Analyzed 100 50
Measure Type: Number
Unit of Measure: Percentage of participants
At least 1 positive serotype; Pre-Inj. 1 Number Analyzed 100 participants 50 participants
31.0 34.0
At least 1 positive serotype; 28 days Post-Inj. 1 Number Analyzed 95 participants 48 participants
78.9 35.4
At least 1 positive serotype; Pre-Inj. 2 Number Analyzed 93 participants 46 participants
67.7 32.6
At least 1 positive serotype; 28 days Post-Inj. 2 Number Analyzed 92 participants 45 participants
100.0 33.3
At least 1 positive serotype; Pre-Inj. 3 Number Analyzed 90 participants 44 participants
90.0 36.4
At least 1 positive serotype; 28 days Post-Inj. 3 Number Analyzed 90 participants 43 participants
100.0 44.2
At least 2 positive serotypes; Pre-Inj. 1 Number Analyzed 100 participants 50 participants
28.0 32.0
At least 2 positive serotypes; 28 days Post-Inj. 1 Number Analyzed 95 participants 48 participants
65.3 35.4
At least 2 positive serotypes; Pre-Inj. 2 Number Analyzed 93 participants 46 participants
46.2 32.6
At least 2 positive serotypes; 28 days Post-Inj. 2 Number Analyzed 92 participants 45 participants
100.0 33.3
At least 2 positive serotypes; Pre-Inj. 3 Number Analyzed 90 participants 44 participants
75.6 34.1
At least 2 positive serotypes; 28 days Post-Inj. 3 Number Analyzed 90 participants 43 participants
100.0 39.5
At least 3 positive serotypes; Pre-Inj. 1 Number Analyzed 100 participants 50 participants
17.0 24.0
At least 3 positive serotypes; 28 days Post-Inj. 1 Number Analyzed 95 participants 48 participants
48.4 27.1
At least 3 positive serotypes; Pre-Inj. 2 Number Analyzed 93 participants 46 participants
33.3 19.6
At least 3 positive serotypes; 28 days Post-Inj. 2 Number Analyzed 92 participants 45 participants
98.9 20.0
At least 3 positive serotypes; Pre-Inj. 3 Number Analyzed 90 participants 44 participants
65.6 27.3
At least 3 positive serotypes; 28 days Post-Inj. 3 Number Analyzed 90 participants 43 participants
98.9 30.2
All 4 positive serotypes; Pre-Inj. 1 Number Analyzed 100 participants 50 participants
9.0 8.0
All 4 positive serotypes; 28 days Post-Inj. 1 Number Analyzed 95 participants 48 participants
31.6 10.4
All 4 positive serotypes; Pre-Inj. 2 Number Analyzed 93 participants 46 participants
25.8 10.9
All 4 positive serotypes; 28 days Post-Inj. 2 Number Analyzed 92 participants 45 participants
63.0 8.9
All 4 positive serotypes; Pre-Inj. 3 Number Analyzed 90 participants 44 participants
27.8 13.6
All 4 positive serotypes; 28 days Post-Inj. 3 Number Analyzed 90 participants 43 participants
77.8 18.6
12.Secondary Outcome
Title Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
Hide Description Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer >=10 1/dilution.
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” signifies participants who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Overall Number of Participants Analyzed 99 49
Measure Type: Number
Unit of Measure: Percentage of participants
At least 1 positive serotype; Pre-Inj. 1 Number Analyzed 99 participants 49 participants
33.3 46.9
At least 1 positive serotype; 28 days Post-Inj. 1 Number Analyzed 98 participants 47 participants
82.7 44.7
At least 1 positive serotype; Pre-Inj. 2 Number Analyzed 96 participants 47 participants
71.9 48.9
At least 1 positive serotype; 28 days Post-Inj. 2 Number Analyzed 96 participants 47 participants
100.0 51.1
At least 1 positive serotype; Pre-Inj. 3 Number Analyzed 96 participants 47 participants
87.5 48.9
At least 1 positive serotype; 28 days Post-Inj. 3 Number Analyzed 96 participants 46 participants
97.9 52.2
At least 2 positive serotypes; Pre-Inj. 1 Number Analyzed 99 participants 49 participants
30.3 44.9
At least 2 positive serotypes; 28 days Post-Inj. 1 Number Analyzed 98 participants 47 participants
68.4 42.6
At least 2 positive serotypes; Pre-Inj. 2 Number Analyzed 96 participants 47 participants
52.1 46.8
At least 2 positive serotypes; 28 days Post-Inj. 2 Number Analyzed 96 participants 47 participants
100.0 46.8
At least 2 positive serotypes; Pre-Inj. 3 Number Analyzed 96 participants 47 participants
75.0 44.7
At least 2 positive serotypes; 28 days Post-Inj. 3 Number Analyzed 96 participants 46 participants
97.9 47.8
At least 3 positive serotypes; Pre-Inj. 1 Number Analyzed 99 participants 49 participants
22.2 24.5
At least 3 positive serotypes; 28 days Post-Inj. 1 Number Analyzed 98 participants 47 participants
57.1 23.4
At least 3 positive serotypes; Pre-Inj. 2 Number Analyzed 96 participants 47 participants
42.7 25.5
At least 3 positive serotypes; 28 days Post-Inj. 2 Number Analyzed 96 participants 47 participants
97.9 23.4
At least 3 positive serotypes; Pre-Inj. 3 Number Analyzed 96 participants 47 participants
69.8 23.4
At least 3 positive serotypes; 28 days Post-Inj. 3 Number Analyzed 96 participants 46 participants
97.9 21.7
All 4 positive serotypes; Pre-Inj. 1 Number Analyzed 99 participants 49 participants
12.1 18.4
All 4 positive serotypes; 28 days Post-Inj. 1 Number Analyzed 98 participants 47 participants
43.9 14.9
All 4 positive serotypes; Pre-Inj. 2 Number Analyzed 96 participants 47 participants
29.2 21.3
All 4 positive serotypes; 28 days Post-Inj. 2 Number Analyzed 96 participants 47 participants
68.8 12.8
All 4 positive serotypes; Pre-Inj. 3 Number Analyzed 96 participants 47 participants
39.6 12.8
All 4 positive serotypes; 28 days Post-Inj. 3 Number Analyzed 96 participants 46 participants
80.2 13.0
13.Secondary Outcome
Title Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
Hide Description Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.
Time Frame Pre-Injection 1 and 28 days Post-Injection 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 specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Overall Number of Participants Analyzed 199 99
Measure Type: Number
Unit of Measure: Percentage of participants
At least 1 positive serotype; Pre-Inj. 1 Number Analyzed 197 participants 99 participants
37.6 48.5
At least 1 positive serotype; 28 days Post-Inj. 2 Number Analyzed 187 participants 92 participants
100.0 57.6
At least 1 positive serotype; 28 days Post-Inj. 3 Number Analyzed 186 participants 89 participants
99.5 73.0
At least 2 positive serotypes; Pre-Inj. 1 Number Analyzed 197 participants 99 participants
31.5 41.4
At least 2 positive serotypes; 28 days Post-Inj. 2 Number Analyzed 187 participants 92 participants
99.5 41.3
At least 2 positive serotypes; 28 days Post-Inj. 3 Number Analyzed 186 participants 89 participants
99.5 52.8
At least 3 positive serotypes; Pre-Inj. 1 Number Analyzed 197 participants 99 participants
29.9 37.4
At least 3 positive serotypes; 28 days Post-Inj. 2 Number Analyzed 187 participants 92 participants
98.4 41.3
At least 3 positive serotypes; 28 days Post-Inj. 3 Number Analyzed 186 participants 89 participants
98.4 46.1
All 4 positive serotypes; Pre-Inj. 1 Number Analyzed 197 participants 99 participants
17.3 19.2
All 4 positive serotypes; 28 days Post-Inj. 2 Number Analyzed 187 participants 92 participants
90.9 29.3
All 4 positive serotypes; 28 days Post-Inj. 3 Number Analyzed 186 participants 89 participants
94.1 39.3
14.Secondary Outcome
Title Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
Hide Description Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >= 10 1/dilution.
Time Frame Pre-Injection 1 and 28 days Post-Injection 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 who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Overall Number of Participants Analyzed 100 50
Measure Type: Number
Unit of Measure: Percentage of participants
At least 1 positive serotype; Pre-Inj. 1 Number Analyzed 99 participants 50 participants
39.4 42.0
At least 1 positive serotype; 28 days Post-Inj. 2 Number Analyzed 92 participants 45 participants
100.0 64.4
At least 1 positive serotype; 28 days Post-Inj. 3 Number Analyzed 90 participants 43 participants
100.0 74.4
At least 2 positive serotypes; Pre-Inj. 1 Number Analyzed 99 participants 50 participants
30.3 36.0
At least 2 positive serotypes; 28 days Post-Inj. 2 Number Analyzed 92 participants 45 participants
100.0 33.3
At least 2 positive serotypes; 28 days Post-Inj. 3 Number Analyzed 90 participants 43 participants
100.0 44.2
At least 3 positive serotypes; Pre-Inj. 1 Number Analyzed 99 participants 50 participants
28.3 34.0
At least 3 positive serotypes; 28 days Post-Inj. 2 Number Analyzed 92 participants 45 participants
97.8 33.3
At least 3 positive serotypes; 28 days Post-Inj. 3 Number Analyzed 90 participants 43 participants
100 41.9
All 4 positive serotypes; Pre-Inj. 1 Number Analyzed 99 participants 50 participants
14.1 16.0
All 4 positive serotypes; 28 days Post-Inj. 2 Number Analyzed 92 participants 45 participants
90.2 26.7
All 4 positive serotypes; 28 days Post-Inj. 3 Number Analyzed 90 participants 43 participants
96.7 37.2
15.Secondary Outcome
Title Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
Hide Description Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution.
Time Frame Pre-Injection 1 and 28 days Post-Injection 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 who were evaluable for this outcome measure and ‘number analyzed’ = participants with available data for specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Overall Number of Participants Analyzed 99 49
Measure Type: Number
Unit of Measure: Percentage of participants
At least 1 positive serotype; Pre-Inj. 1 Number Analyzed 98 participants 49 participants
35.7 55.1
At least 1 positive serotype; 28 days Post-Inj. 2 Number Analyzed 95 participants 47 participants
100.0 51.1
At least 1 positive serotype; 28 days Post-Inj. 3 Number Analyzed 96 participants 46 participants
99.0 71.7
At least 2 positive serotypes; Pre-Inj. 1 Number Analyzed 98 participants 49 participants
32.7 46.9
At least 2 positive serotypes; 28 days Post-Inj. 2 Number Analyzed 95 participants 47 participants
98.9 48.9
At least 2 positive serotypes; 28 days Post-Inj. 3 Number Analyzed 96 participants 46 participants
99.0 60.9
At least 3 positive serotypes; Pre-Inj. 1 Number Analyzed 98 participants 49 participants
31.6 40.8
At least 3 positive serotypes; 28 days Post-Inj. 2 Number Analyzed 95 participants 47 participants
98.9 48.9
At least 3 positive serotypes; 28 days Post-Inj. 3 Number Analyzed 96 participants 46 participants
96.9 50.0
All 4 positive serotypes; Pre-Inj. 1 Number Analyzed 98 participants 49 participants
20.4 22.4
All 4 positive serotypes; 28 days Post-Inj. 2 Number Analyzed 95 participants 47 participants
91.6 31.9
All 4 positive serotypes; 28 days Post-Inj. 3 Number Analyzed 96 participants 46 participants
91.7 41.3
16.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Hide Description GMTs of antibodies against parental dengue virus serotypes were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
Time Frame Pre-Injection 1 and 28 days Post-Injection 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 specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Overall Number of Participants Analyzed 199 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Serotype 1; Pre-Inj. 1, All Number Analyzed 196 participants 99 participants
17.4
(13.0 to 23.2)
22.8
(14.9 to 34.8)
Serotype 1; 28 days Post-Inj. 2, All Number Analyzed 187 participants 92 participants
125
(98.5 to 159)
26.4
(16.7 to 41.8)
Serotype 1; 28 days Post-Inj. 3, All Number Analyzed 186 participants 89 participants
179
(143 to 224)
38.1
(23.4 to 62.1)
Serotype 2; Pre-Inj. 1, All Number Analyzed 197 participants 99 participants
14.4
(11.2 to 18.3)
18.2
(12.8 to 25.8)
Serotype 2; 28 days Post-Inj. 2, All Number Analyzed 187 participants 92 participants
151
(128 to 178)
17.3
(12.5 to 23.9)
Serotype 2; 28 days Post-Inj. 3, All Number Analyzed 186 participants 89 participants
178
(152 to 207)
21.6
(14.8 to 31.5)
Serotype 3; Pre-Inj. 1, All Number Analyzed 197 participants 99 participants
16.4
(12.7 to 21.2)
21.8
(15.2 to 31.3)
Serotype 3; 28 days Post-Inj. 2, All Number Analyzed 187 participants 92 participants
155
(129 to 186)
26.6
(18.1 to 39.0)
Serotype 3; 28 days Post-Inj. 3, All Number Analyzed 186 participants 89 participants
190
(162 to 224)
36.2
(25.1 to 52.0)
Serotype 4; Pre-Inj. 1, All Number Analyzed 197 participants 99 participants
8.12
(6.91 to 9.54)
8.94
(6.97 to 11.5)
Serotype 4; 28 days Post-Inj. 2, All Number Analyzed 185 participants 92 participants
144
(126 to 166)
12.8
(9.50 to 17.2)
Serotype 4; 28 days Post-Inj. 3, All Number Analyzed 185 participants 89 participants
184
(159 to 212)
16.7
(12.2 to 22.8)
Serotype 1; Pre-Inj. 1, 2-5 years Number Analyzed 99 participants 50 participants
16.4
(11.1 to 24.3)
16.2
(9.47 to 27.5)
Serotype 1; 28 days Post-Inj. 2, 2-5 years Number Analyzed 92 participants 45 participants
135
(97.2 to 187)
19.0
(10.1 to 35.7)
Serotype 1; 28 days Post-Inj. 3, 2-5 years Number Analyzed 90 participants 43 participants
205
(149 to 282)
31.3
(14.9 to 65.9)
Serotype 2; Pre-Inj. 1, 2-5 years Number Analyzed 99 participants 50 participants
11.8
(8.94 to 15.6)
13.9
(9.31 to 20.6)
Serotype 2; 28 days Post-Inj. 2, 2-5 years Number Analyzed 92 participants 45 participants
135
(109 to 168)
13.2
(8.80 to 19.9)
Serotype 2; 28 days Post-Inj. 3, 2-5 years Number Analyzed 90 participants 43 participants
195
(163 to 234)
21.8
(12.1 to 39.2)
Serotype 3; Pre-Inj. 1, 2-5 years Number Analyzed 99 participants 50 participants
16.2
(11.2 to 23.4)
16.7
(10.2 to 27.4)
Serotype 3; 28 days Post-Inj. 2, 2-5 years Number Analyzed 92 participants 45 participants
171
(131 to 224)
26.5
(15.4 to 45.7)
Serotype 3; 28 days Post-Inj. 3, 2-5 years Number Analyzed 90 participants 43 participants
214
(169 to 270)
35.0
(20.3 to 60.6)
Serotype 4; Pre-Inj. 1, 2-5 years Number Analyzed 99 participants 50 participants
7.76
(6.20 to 9.70)
9.02
(6.27 to 13.0)
Serotype 4; 28 days Post-Inj. 2, 2-5 years Number Analyzed 90 participants 45 participants
165
(134 to 203)
14.4
(8.83 to 23.6)
Serotype 4; 28 days Post-Inj. 3, 2-5 years Number Analyzed 90 participants 43 participants
223
(181 to 276)
18.7
(11.2 to 31.4)
Serotype 1; Pre-Inj. 1, 6-11 years Number Analyzed 97 participants 49 participants
18.4
(12.0 to 28.4)
32.3
(16.6 to 63.1)
Serotype 1; 28 days Post-Inj. 2, 6-11 years Number Analyzed 95 participants 47 participants
116
(81.7 to 165)
36.2
(18.5 to 71.0)
Serotype 1; 28 days Post-Inj. 3, 6-11 years Number Analyzed 96 participants 46 participants
157
(115 to 216)
45.8
(23.6 to 88.8)
Serotype 2; Pre-Inj. 1, 6-11 years Number Analyzed 98 participants 49 participants
17.5
(11.6 to 26.3)
24.0
(13.4 to 43.1)
Serotype 2; 28 days Post-Inj. 2, 6-11 years Number Analyzed 95 participants 47 participants
168
(130 to 216)
22.3
(13.4 to 37.0)
Serotype 2; 28 days Post-Inj. 3, 6-11 years Number Analyzed 96 participants 46 participants
163
(127 to 208)
21.4
(12.9 to 35.6)
Serotype 3; Pre-Inj. 1, 6-11 years Number Analyzed 98 participants 49 participants
16.6
(11.5 to 24.0)
28.6
(16.7 to 48.7)
Serotype 3; 28 days Post-Inj. 2, 6-11 years Number Analyzed 95 participants 47 participants
141
(109 to 182)
26.6
(15.1 to 46.8)
Serotype 3; 28 days Post-Inj. 3, 6-11 years Number Analyzed 96 participants 46 participants
171
(137 to 213)
37.3
(22.5 to 61.6)
Serotype 4; Pre-Inj. 1, 6-11 years Number Analyzed 98 participants 49 participants
8.50
(6.72 to 10.8)
8.87
(6.21 to 12.6)
Serotype 4; 28 days Post-Inj. 2, 6-11 years Number Analyzed 95 participants 47 participants
127
(106 to 153)
11.4
(7.96 to 16.3)
Serotype 4; 28 days Post-Inj. 3, 6-11 years Number Analyzed 95 participants 46 participants
152
(126 to 184)
15.0
(10.2 to 22.0)
17.Secondary Outcome
Title Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity for yellow fever was assessed by the PRNT. Seropositivity was defined as a titer >=10 1/dilution. Percentage values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
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, 'number analyzed' = participants with available data for specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Overall Number of Participants Analyzed 199 99
Measure Type: Number
Unit of Measure: Percentage of participants
Pre-Inj. 1; All participants Number Analyzed 199 participants 99 participants
81.4 83.8
28 days Post-Inj. 1; All participants Number Analyzed 192 participants 95 participants
86.5 83.2
Pre-Inj. 1; 2-5 years Number Analyzed 100 participants 50 participants
68.0 74.0
28 days Post-Inj. 1; 2-5 years Number Analyzed 94 participants 48 participants
76.6 72.9
Pre-Inj. 1; 6-11 years Number Analyzed 99 participants 49 participants
94.9 93.9
28 days Post-Inj. 1; 6-11 years Number Analyzed 98 participants 47 participants
95.9 93.6
18.Secondary Outcome
Title GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo
Hide Description GMTs of antibodies against yellow fever virus were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
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, 'number analyzed' = participants with available data for specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Overall Number of Participants Analyzed 199 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Pre-Inj. 1; All participants Number Analyzed 199 participants 99 participants
32.3
(26.5 to 39.4)
36.0
(27.1 to 47.7)
28 days Post-Inj. 1; All participants Number Analyzed 192 participants 95 participants
43.7
(36.1 to 52.8)
36.0
(27.3 to 47.3)
Pre-Inj. 1; 2-5 years Number Analyzed 100 participants 50 participants
15.9
(12.3 to 20.6)
20.5
(13.7 to 30.7)
28 days Post-Inj. 1; 2-5 years Number Analyzed 94 participants 48 participants
22.4
(17.5 to 28.7)
21.2
(14.4 to 31.1)
Pre-Inj. 1; 6-11 years Number Analyzed 99 participants 49 participants
66.1
(52.8 to 82.9)
63.9
(45.8 to 89.2)
28 days Post-Inj. 1; 6-11 years Number Analyzed 98 participants 47 participants
82.9
(66.2 to 104)
61.8
(44.0 to 86.7)
19.Secondary Outcome
Title GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Hide Description GMTs of antibodies against parental dengue virus serotypes were assessed by the microneutralization assay. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
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, 'number analyzed' = participants with available data for specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
Overall Number of Participants Analyzed 199 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Serotype 1; Pre-Inj. 1, All Number Analyzed 199 participants 99 participants
18.8
(13.8 to 25.6)
23.9
(15.5 to 36.9)
Serotype 1; 28 days Post-Inj.1, All Number Analyzed 193 participants 95 participants
43.1
(30.0 to 61.9)
22.8
(14.8 to 35.1)
Serotype 1; Pre-Inj. 2, All Number Analyzed 189 participants 92 participants
29.2
(20.5 to 41.7)
26.0
(16.2 to 41.5)
Serotype 1; 28 days Post-Inj. 2, All Number Analyzed 188 participants 92 participants
214
(171 to 266)
26.1
(16.3 to 42.0)
Serotype 1; Pre-Inj. 3, All Number Analyzed 186 participants 91 participants
64.1
(46.1 to 89.2)
28.9
(17.7 to 49.3)
Serotype 1; 28 days Post-Inj. 3, All Number Analyzed 186 participants 89 participants
254
(203 to 318)
35.3
(21.2 to 58.7)
Serotype 2; Pre-Inj. 1, All Number Analyzed 199 participants 99 participants
7.55
(6.50 to 8.78)
7.76
(6.31 to 9.53)
Serotype 2; 28 days Post-Inj.1, All Number Analyzed 193 participants 95 participants
15.5
(12.4 to 19.4)
7.51
(6.19 to 9.12)
Serotype 2; Pre-Inj. 2, All Number Analyzed 189 participants 93 participants
11.6
(9.52 to 14.1)
7.32
(6.06 to 8.84)
Serotype 2; 28 days Post-Inj. 2, All Number Analyzed 188 participants 92 participants
21.4
(17.6 to 25.9)
6.99
(5.82 to 8.39)
Serotype 2; Pre-Inj. 3, All Number Analyzed 186 participants 91 participants
11.4
(9.39 to 13.8)
7.26
(6.01 to 8.78)
Serotype 2; 28 days Post-Inj. 3, All Number Analyzed 186 participants 89 participants
22.3
(18.9 to 26.4)
7.73
(6.24 to 9.58)
Serotype 3; Pre-Inj. 1, All Number Analyzed 199 participants 99 participants
13.1
(10.3 to 16.5)
16.3
(11.6 to 22.8)
Serotype 3; 28 days Post-Inj.1, All Number Analyzed 193 participants 95 participants
41.4
(30.9 to 55.4)
15.3
(11.0 to 21.3)
Serotype 3; Pre-Inj. 2, All Number Analyzed 189 participants 93 participants
22.6
(17.3 to 29.5)
15.4
(11.2 to 21.2)
Serotype 3; 28 days Post-Inj. 2, All Number Analyzed 188 participants 92 participants
128
(108 to 150)
15.5
(11.2 to 21.5)
Serotype 3; Pre-Inj. 3, All Number Analyzed 186 participants 91 participants
31.0
(24.3 to 39.6)
14.0
(10.3 to 19.0)
Serotype 3; 28 days Post-Inj. 3, All Number Analyzed 186 participants 89 participants
99.2
(84.8 to 116)
16.0
(11.5 to 22.2)
Serotype 4; Pre-Inj. 1, All Number Analyzed 199 participants 99 participants
7.52
(6.37 to 8.87)
8.08
(6.39 to 10.2)
Serotype 4; 28 days Post-Inj.1, All Number Analyzed 193 participants 95 participants
87.9
(65.4 to 118)
7.84
(6.25 to 9.83)
Serotype 4; Pre-Inj. 2, All Number Analyzed 189 participants 93 participants
21.3
(16.9 to 26.8)
7.73
(6.27 to 9.53)
Serotype 4; 28 days Post-Inj. 2, All Number Analyzed 188 participants 92 participants
158
(134 to 186)
7.81
(6.27 to 9.74)
Serotype 4; Pre-Inj. 3, All Number Analyzed 186 participants 91 participants
39.2
(31.7 to 48.5)
7.49
(6.06 to 9.26)
Serotype 4; 28 days Post-Inj. 3, All Number Analyzed 186 participants 89 participants
147
(126 to 172)
8.54
(6.71 to 10.9)
Serotype 1; Pre-Inj. 1, 2-5 years Number Analyzed 100 participants 50 participants
20.3
(12.9 to 32.0)
18.6
(10.4 to 33.4)
Serotype 1; 28 days Post-Inj. 1, 2-5 years Number Analyzed 95 participants 48 participants
44.8
(25.9 to 77.3)
19.6
(10.6 to 36.1)
Serotype 1; Pre-Inj. 2, 2-5 years Number Analyzed 93 participants 45 participants
31.3
(18.1 to 53.9)
19.7
(10.1 to 38.2)
Serotype 1; 28 days Post-Inj. 2, 2-5 years Number Analyzed 92 participants 45 participants
281
(204 to 386)
20.9
(10.5 to 41.7)
Serotype 1; Pre-Inj. 3, 2-5 years Number Analyzed 90 participants 44 participants
65.2
(39.6 to 107)
22.1
(11.0 to 44.5)
Serotype 1; 28 days Post-Inj. 3, 2-5 years Number Analyzed 90 participants 43 participants
315
(228 to 436)
35.9
(16.4 to 78.6)
Serotype 2; Pre-Inj. 1, 2-5 years Number Analyzed 100 participants 50 participants
6.66
(5.63 to 7.88)
6.48
(5.30 to 7.92)
Serotype 2; 28 days Post-Inj. 1, 2-5 years Number Analyzed 95 participants 48 participants
12.7
(9.35 to 17.3)
6.73
(5.39 to 8.41)
Serotype 2; Pre-Inj. 2, 2-5 years Number Analyzed 93 participants 46 participants
10.1
(7.85 to 12.9)
6.28
(5.19 to 7.61)
Serotype 2; 28 days Post-Inj. 2, 2-5 years Number Analyzed 92 participants 45 participants
17.1
(13.4 to 21.8)
6.13
(5.06 to 7.44)
Serotype 2; Pre-Inj. 3, 2-5 years Number Analyzed 90 participants 44 participants
9.03
(7.17 to 11.4)
6.68
(5.37 to 8.32)
Serotype 2; 28 days Post-Inj. 3, 2-5 years Number Analyzed 90 participants 43 participants
19.7
(15.9 to 24.5)
7.93
(5.76 to 10.9)
Serotype 3; Pre-Inj. 1, 2-5 years Number Analyzed 100 participants 50 participants
11.8
(8.54 to 16.4)
12.2
(8.00 to 18.7)
Serotype 3; 28 days Post-Inj. 1, 2-5 years Number Analyzed 95 participants 48 participants
37.4
(23.9 to 58.3)
12.9
(8.39 to 20.0)
Serotype 3; Pre-Inj. 2, 2-5 years Number Analyzed 93 participants 46 participants
19.8
(13.4 to 29.4)
12.3
(7.92 to 19.0)
Serotype 3; 28 days Post-Inj. 2, 2-5 years Number Analyzed 92 participants 45 participants
129
(104 to 160)
12.6
(8.01 to 19.7)
Serotype 3; Pre-Inj. 3, 2-5 years Number Analyzed 90 participants 44 participants
26.7
(18.7 to 38.2)
12.2
(7.85 to 19.1)
Serotype 3; 28 days Post-Inj. 3, 2-5 years Number Analyzed 90 participants 43 participants
108
(86.9 to 135)
15.3
(9.29 to 25.2)
Serotype 4; Pre-Inj. 1, 2-5 years Number Analyzed 100 participants 50 participants
7.04
(5.67 to 8.74)
7.74
(5.60 to 10.7)
Serotype 4; 28 days Post-Inj. 1, 2-5 years Number Analyzed 95 participants 48 participants
114
(74.0 to 176)
8.43
(5.97 to 11.9)
Serotype 4; Pre-Inj. 2, 2-5 years Number Analyzed 93 participants 46 participants
22.3
(16.0 to 31.0)
7.64
(5.53 to 10.6)
Serotype 4; 28 days Post-Inj. 2, 2-5 years Number Analyzed 92 participants 45 participants
200
(166 to 240)
8.22
(5.76 to 11.7)
Serotype 4; Pre-Inj. 3, 2-5 years Number Analyzed 90 participants 44 participants
39.4
(29.5 to 52.8)
7.97
(5.69 to 11.2)
Serotype 4; 28 days Post-Inj. 3, 2-5 years Number Analyzed 90 participants 43 participants
176
(143 to 217)
9.37
(6.35 to 13.8)
Serotype 1; Pre-Inj. 1, 6-11 years Number Analyzed 99 participants 49 participants
17.4
(11.4 to 26.6)
31.0
(16.1 to 59.6)
Serotype 1; 28 days Post-Inj. 1, 6-11 years Number Analyzed 98 participants 47 participants
41.5
(25.5 to 67.5)
26.7
(14.2 to 50.0)
Serotype 1; Pre-Inj. 2, 6-11 years Number Analyzed 96 participants 47 participants
27.4
(17.2 to 43.6)
33.9
(17.2 to 66.9)
Serotype 1; 28 days Post-Inj. 2, 6-11 years Number Analyzed 96 participants 47 participants
165
(122 to 222)
32.4
(16.6 to 63.2)
Serotype 1; Pre-Inj. 3, 6-11 years Number Analyzed 96 participants 47 participants
63.2
(40.5 to 98.7)
37.2
(18.4 to 75.4)
Serotype 1;28 days Post-Inj. 3, 6-11 years Number Analyzed 96 participants 46 participants
207
(152 to 283)
34.7
(17.4 to 69.1)
Serotype 2; Pre-Inj. 1, 6-11 years Number Analyzed 99 participants 49 participants
8.57
(6.67 to 11.0)
9.32
(6.48 to 13.4)
Serotype 2; 28 days Post-Inj. 1, 6-11 years Number Analyzed 98 participants 47 participants
18.8
(13.5 to 26.2)
8.40
(6.07 to 11.6)
Serotype 2; Pre-Inj. 2, 6-11 years Number Analyzed 96 participants 47 participants
13.3
(9.80 to 18.0)
8.50
(6.14 to 11.8)
Serotype 2; 28 days Post-Inj. 2, 6-11 years Number Analyzed 96 participants 47 participants
26.5
(19.7 to 35.7)
7.92
(5.82 to 10.8)
Serotype 2; Pre-Inj. 3, 6-11 years Number Analyzed 96 participants 47 participants
14.1
(10.5 to 19.0)
7.85
(5.75 to 10.7)
Serotype 2; 28 days Post-Inj. 3, 6-11 years Number Analyzed 96 participants 46 participants
25.0
(19.4 to 32.3)
7.55
(5.59 to 10.2)
Serotype 3; Pre-Inj. 1, 6-11 years Number Analyzed 99 participants 49 participants
14.4
(10.3 to 20.2)
21.8
(12.8 to 37.1)
Serotype 3; 28 days Post-Inj. 1, 6-11 years Number Analyzed 98 participants 47 participants
45.6
(31.0 to 67.1)
18.3
(11.0 to 30.4)
Serotype 3; Pre-Inj. 2, 6-11 years Number Analyzed 96 participants 47 participants
25.6
(17.8 to 37.0)
19.2
(11.9 to 31.1)
Serotype 3; 28 days Post-Inj. 2, 6-11 years Number Analyzed 96 participants 47 participants
126
(98.6 to 162)
19.1
(11.8 to 30.8)
Serotype 3; Pre-Inj. 3, 6-11 years Number Analyzed 96 participants 47 participants
35.6
(25.3 to 50)
15.8
(10.2 to 24.6)
Serotype 3; 28 days Post-Inj. 3, 6-11 years Number Analyzed 96 participants 46 participants
91.3
(73.0 to 114)
16.7
(10.7 to 26.0)
Serotype 4; Pre-Inj. 1, 6-11 years Number Analyzed 99 participants 49 participants
8.03
(6.23 to 10.3)
8.43
(5.94 to 12.0)
Serotype 4; 28 days Post-Inj. 1, 6-11 years Number Analyzed 98 participants 47 participants
68.2
(45.6 to 102)
7.28
(5.36 to 9.88)
Serotype 4; Pre-Inj. 2, 6-11 years Number Analyzed 96 participants 47 participants
20.3
(14.6 to 28.1)
7.82
(5.90 to 10.3)
Serotype 4; 28 days Post-Inj. 2, 6-11 years Number Analyzed 96 participants 47 participants
126
(96.3 to 164)
7.44
(5.63 to 9.83)
Serotype 4; Pre-Inj. 3, 6-11 years Number Analyzed 96 participants 47 participants
39.0
(28.6 to 53.2)
7.06
(5.37 to 9.29)
Serotype 4; 28 days Post-Inj. 3, 6-11 years Number Analyzed 96 participants 46 participants
125
(98.9 to 157)
7.82
(5.79 to 10.6)
Time Frame Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Adverse Event Reporting Description Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
 
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months). Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
All-Cause Mortality
CYD Dengue Vaccine Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/199 (0.00%)      0/99 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
CYD Dengue Vaccine Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/199 (1.01%)      4/99 (4.04%)    
Gastrointestinal disorders     
Food poisoning * 1  0/199 (0.00%)  0 1/99 (1.01%)  1
Inguinal hernia * 1  0/199 (0.00%)  0 1/99 (1.01%)  2
Infections and infestations     
Gastrointestinal infection * 1  0/199 (0.00%)  0 1/99 (1.01%)  1
Pneumonia * 1  0/199 (0.00%)  0 1/99 (1.01%)  1
Musculoskeletal and connective tissue disorders     
Epiphyseal disorder * 1  1/199 (0.50%)  1 0/99 (0.00%)  0
Skin and subcutaneous tissue disorders     
Vascular purpura * 1  1/199 (0.50%)  1 0/99 (0.00%)  0
1
Term from vocabulary, MedDRA 11.0
*
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 Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   71/199 (35.68%)      29/99 (29.29%)    
General disorders     
Injection site Pain; Post-injection 1, All participants  1  41/199 (20.60%)  41 17/99 (17.17%)  17
Injection site Erythema; Post-injection 1, All participants  1  15/199 (7.54%)  15 4/99 (4.04%)  4
Injection site Swelling; Post-injection 1, all participants  1  11/199 (5.53%)  11 5/99 (5.05%)  5
Injection site Pain; Post-injection 2, All participants  1  37/188 (19.68%)  37 16/92 (17.39%)  16
Injection site Pain; Post-injection 3, All participants  1  33/186 (17.74%)  33 29/90 (32.22%)  29
Injection site Erythema; Post-injection 3, All participants  1  8/186 (4.30%)  8 10/90 (11.11%)  10
Injection site Swelling; Post-injection 3, All participants  1  6/186 (3.23%)  6 8/90 (8.89%)  8
1
Term from vocabulary, MedDRA 11.0
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 participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director
Organization: Sanofi Pasteur SA
EMail: Contact-US@sanofi.com
Other Publications:
Crevat D. Immunogenicity and safety of tetravalent dengue vaccine in healthy Peruvian children aged 2 to 11 years, previously-vaccinated against yellow fever. "A re-emerging challenge in the Americas: opportunities for dengue research collaboration" Conference. Feb 15-18, 2011; San Juan, Puerto Rico.
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00788151     History of Changes
Other Study ID Numbers: CYD24
2014-001711-40 ( EudraCT Number )
First Submitted: November 7, 2008
First Posted: November 10, 2008
Results First Submitted: May 24, 2019
Results First Posted: July 29, 2019
Last Update Posted: August 14, 2019