Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    CYD28
Previous Study | Return to List | Next Study

Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore

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: NCT00880893
Recruitment Status : Completed
First Posted : April 14, 2009
Results First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Dengue Fever
Dengue Hemorrhagic Fever
Dengue Virus
Dengue Diseases
Interventions Biological: CYD Dengue vaccine
Biological: NaCl + influenza virus or hepatitis A vaccine
Enrollment 1198
Recruitment Details Study participants were enrolled from 07 April 2009 to 08 October 2009 at 5 clinical sites in Singapore.
Pre-assignment Details A total of 1198 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 the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively. All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Period Title: Overall Study
Started 898 300
Completed 791 255
Not Completed 107 45
Reason Not Completed
Protocol Violation             13             1
Withdrawal by Subject             15             11
Lost to Follow-up             76             33
Serious adverse event             3             0
Arm/Group Title CYD Dengue Vaccine Group Placebo Group Total
Hide Arm/Group Description Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively. All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations. Total of all reporting groups
Overall Number of Baseline Participants 898 300 1198
Hide Baseline Analysis Population Description
Analysis was performed on Safety analysis set which included all participants who had received at least one dose of CYD dengue or control vaccine.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 898 participants 300 participants 1198 participants
22.1  (12.0) 21.7  (11.8) 22.0  (11.9)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 898 participants 300 participants 1198 participants
2-11 years
236
  26.3%
80
  26.7%
316
  26.4%
12-17 years
141
  15.7%
46
  15.3%
187
  15.6%
18-45 years
521
  58.0%
174
  58.0%
695
  58.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 898 participants 300 participants 1198 participants
Female
471
  52.4%
139
  46.3%
610
  50.9%
Male
427
  47.6%
161
  53.7%
588
  49.1%
1.Primary Outcome
Title Percentage of All Participants 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. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions (2-11 years): Pain, incapacitating, unable to perform usual activities; Erythema and Swelling, >=5 cm. Grade 3 Solicited injection site reactions (adolescents and adults: >=12 years): Pain, significant; prevents daily activity; Erythema and Swelling: >10 cm. Grade 3 Solicited systemic reactions (all participants): Fever, >=39.0°C; Headache, Malaise, Myalgia, and Asthenia: significant; prevents daily activity.
Time Frame Day 0 up to 14 days post-any and each injection
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety analysis set. Here, ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 898 300
Measure Type: Number
Unit of Measure: Percentage of participants
Injection site Pain; Post-Any Injection Number Analyzed 892 participants 297 participants
53.9 66.7
Grade 3 Injection site Pain; Post-Any Injection Number Analyzed 892 participants 297 participants
1.0 2.0
Injection site Erythema; Post-Any Injection Number Analyzed 891 participants 297 participants
7.2 15.2
Grade 3 Inj. site Erythema; Post-Any Inj. Number Analyzed 891 participants 297 participants
0.0 0.0
Injection site Swelling; Post-Any Injection Number Analyzed 892 participants 297 participants
4.1 8.4
Grade 3 Inj. site Swelling; Post-Any Inj. Number Analyzed 892 participants 297 participants
0.0 0.0
Injection site Pain; Post-Injection 1 Number Analyzed 892 participants 297 participants
31.3 21.9
Grade 3 Injection site Pain; Post- Injection 1 Number Analyzed 892 participants 297 participants
0.3 0.7
Injection site Erythema; Post-Injection 1 Number Analyzed 891 participants 297 participants
2.0 2.0
Grade 3 Injection site Erythema; Post- Injection 1 Number Analyzed 891 participants 297 participants
0.0 0.0
Injection site Swelling; Post-Injection 1 Number Analyzed 892 participants 297 participants
1.1 1.7
Grade 3 Injection site Swelling; Post- Injection 1 Number Analyzed 892 participants 297 participants
0.0 0.0
Injection site Pain; Post-Injection 2 Number Analyzed 859 participants 285 participants
36.9 54.4
Grade 3 Injection site Pain; Post- Injection 2 Number Analyzed 859 participants 285 participants
0.5 0.7
Injection site Erythema; Post-Injection 2 Number Analyzed 859 participants 285 participants
3.4 8.8
Grade 3 Injection site Erythema; Post- Injection 2 Number Analyzed 859 participants 285 participants
0.0 0.0
Injection site Swelling; Post-Injection 2 Number Analyzed 859 participants 285 participants
1.4 3.5
Grade 3 Injection site Swelling; Post- Injection 2 Number Analyzed 859 participants 285 participants
0.0 0.0
Injection site Pain; Post-Injection 3 Number Analyzed 836 participants 278 participants
34.9 50.0
Grade 3 Injection site Pain; Post- Injection 3 Number Analyzed 836 participants 278 participants
0.2 0.7
Injection site Erythema; Post-Injection 3 Number Analyzed 836 participants 278 participants
3.8 9.4
Grade 3 Injection site Erythema; Post- Injection 3 Number Analyzed 836 participants 278 participants
0.0 0.0
Injection site Swelling; Post-Injection 3 Number Analyzed 836 participants 278 participants
2.6 5.8
Grade 3 Injection site Swelling; Post- Injection 3 Number Analyzed 836 participants 278 participants
0.0 0.0
Fever; Post-Any Injection Number Analyzed 892 participants 297 participants
11.3 7.4
Grade 3 Fever; Post-Any Injection Number Analyzed 892 participants 297 participants
1.9 1.0
Headache; Post-Any Injection Number Analyzed 891 participants 297 participants
45.1 38.4
Grade 3 Headache; Post-Any Injection Number Analyzed 891 participants 297 participants
3.8 2.7
Malaise; Post-Any Injection Number Analyzed 891 participants 297 participants
41.8 35.4
Grade 3 Malaise; Post-Any Injection Number Analyzed 891 participants 297 participants
4.3 2.7
Myalgia; Post-Any Injection Number Analyzed 891 participants 297 participants
44.2 43.8
Grade 3 Myalgia; Post-Any Injection Number Analyzed 891 participants 297 participants
2.6 2.0
Asthenia; Post-Any Injection Number Analyzed 891 participants 297 participants
20.5 17.5
Grade 3 Asthenia; Post-Any Injection Number Analyzed 891 participants 297 participants
1.3 0.7
Fever; Post-Injection 1 Number Analyzed 891 participants 297 participants
4.6 2.7
Grade 3 Fever; Post-Injection 1 Number Analyzed 891 participants 297 participants
0.6 0.7
Headache; Post-Injection 1 Number Analyzed 891 participants 297 participants
30.0 27.3
Grade 3 Headache; Post-Injection 1 Number Analyzed 891 participants 297 participants
2.4 1.3
Malaise; Post-Injection 1 Number Analyzed 891 participants 297 participants
25.0 18.2
Grade 3 Malaise; Post-Injection 1 Number Analyzed 891 participants 297 participants
2.0 0.7
Myalgia; Post-Injection 1 Number Analyzed 891 participants 297 participants
29.4 19.2
Grade 3 Myalgia; Post-Injection 1 Number Analyzed 891 participants 297 participants
1.3 1.0
Asthenia; Post-Injection 1 Number Analyzed 891 participants 297 participants
12.8 6.1
Grade 3 Asthenia; Post-Injection 1 Number Analyzed 891 participants 297 participants
0.7 0.3
Fever; Post-Injection 2 Number Analyzed 859 participants 285 participants
3.3 2.8
Grade 3 Fever; Post-Injection 2 Number Analyzed 859 participants 285 participants
0.6 0.0
Headache; Post-Injection 2 Number Analyzed 859 participants 285 participants
22.8 21.8
Grade 3 Headache; Post-Injection 2 Number Analyzed 859 participants 285 participants
0.7 1.1
Malaise; Post-Injection 2 Number Analyzed 859 participants 285 participants
19.1 18.2
Grade 3 Malaise; Post-Injection 2 Number Analyzed 859 participants 285 participants
1.2 1.1
Myalgia; Post-Injection 2 Number Analyzed 859 participants 285 participants
24.0 29.5
Grade 3 Myalgia; Post-Injection 2 Number Analyzed 859 participants 285 participants
0.9 0.7
Asthenia; Post-Injection 2 Number Analyzed 859 participants 285 participants
9.3 10.2
Grade 3 Asthenia; Post-Injection 2 Number Analyzed 859 participants 285 participants
0.3 0.0
Fever; Post-Injection 3 Number Analyzed 836 participants 278 participants
4.8 2.9
Grade 3 Fever; Post-Injection 3 Number Analyzed 836 participants 278 participants
0.8 0.4
Headache; Post-Injection 3 Number Analyzed 836 participants 278 participants
20.1 19.8
Grade 3 Headache; Post-Injection 3 Number Analyzed 836 participants 278 participants
1.0 0.4
Malaise; Post-Injection 3 Number Analyzed 836 participants 278 participants
18.2 17.3
Grade 3 Malaise; Post-Injection 3 Number Analyzed 836 participants 278 participants
1.4 1.1
Myalgia; Post-Injection 3 Number Analyzed 836 participants 278 participants
21.8 26.3
Grade 3 Myalgia; Post-Injection 3 Number Analyzed 836 participants 278 participants
0.5 0.7
Asthenia; Post-Injection 3 Number Analyzed 836 participants 278 participants
8.5 9.4
Grade 3 Asthenia; Post-Injection 3 Number Analyzed 836 participants 278 participants
0.4 0.4
2.Primary Outcome
Title Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 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. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia.
Time Frame Day 0 up to 14 days post-each injection
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety analysis set. Here, ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 898 300
Measure Type: Number
Unit of Measure: Percentage of participants
2-11 years; Injection site Pain, Post-Inj. 1 Number Analyzed 236 participants 80 participants
33.9 30.0
2-11 years; Inj. site Erythema, Post-Inj. 1 Number Analyzed 236 participants 80 participants
6.4 7.5
2-11 years; Inj. site Swelling, Post-Inj. 1 Number Analyzed 236 participants 80 participants
3.8 6.3
12-17 years; Injection site Pain, Post- Inj. 1 Number Analyzed 141 participants 46 participants
28.4 28.3
12-17 years; Inj. site Erythema, Post- Inj. 1 Number Analyzed 140 participants 46 participants
0.0 0.0
12-17 years; Inj. site Swelling, Post-Inj. 1 Number Analyzed 141 participants 46 participants
0.0 0.0
18-45 years; Injection site Pain, Post- Inj. 1 Number Analyzed 515 participants 171 participants
30.9 16.4
18-45 years; Inj. site Erythema, Post- Inj. 1 Number Analyzed 515 participants 171 participants
0.6 0.0
18-45 years; Inj. site Swelling, Post-Inj. 1 Number Analyzed 515 participants 171 participants
0.2 0.0
2-11 years; Injection site Pain, Post- Inj. 2 Number Analyzed 235 participants 76 participants
38.3 42.1
2-11 years; Inj. site Erythema, Post-Inj. 2 Number Analyzed 235 participants 76 participants
9.4 5.3
2-11 years; Inj. site Swelling, Post-Inj. 2 Number Analyzed 235 participants 76 participants
4.7 3.9
12-17 years; Injection site Pain, Post- Inj. 2 Number Analyzed 136 participants 45 participants
29.4 44.4
12-17 years; Inj. site Erythema, Post- Inj. 2 Number Analyzed 136 participants 45 participants
0.0 0.0
12-17 years; Inj. site Swelling, Post-Inj. 2 Number Analyzed 136 participants 45 participants
0.0 0.0
18-45 years; Injection site Pain, Post- Inj. 2 Number Analyzed 488 participants 164 participants
38.3 62.8
18-45 years; Inj. site Erythema, Post- Inj. 2 Number Analyzed 488 participants 164 participants
1.4 12.8
18-45 years; Inj. site Swelling, Post-Inj. 2 Number Analyzed 488 participants 164 participants
0.2 4.3
2-11 years; Injection site Pain, Post- Inj. 3 Number Analyzed 233 participants 76 participants
32.6 34.2
2-11 years; Inj. site Erythema, Post-Inj. 3 Number Analyzed 233 participants 76 participants
8.2 6.6
2-11 years; Inj. site Swelling, Post-Inj. 3 Number Analyzed 233 participants 76 participants
6.4 2.6
12-17 years; Injection site Pain, Post- Inj. 3 Number Analyzed 135 participants 44 participants
26.7 38.6
12-17 years; Inj. site Erythema, Post- Inj. 3 Number Analyzed 135 participants 44 participants
0.0 0.0
12-17 years; Inj. site Swelling, Post-Inj. 3 Number Analyzed 135 participants 44 participants
0.0 0.0
18-45 years; Injection site Pain, Post- Inj. 3 Number Analyzed 468 participants 158 participants
38.5 60.8
18-45 years; Inj. site Erythema, Post- Inj. 3 Number Analyzed 468 participants 158 participants
2.8 13.3
18-45 years; Inj. site Swelling, Post-Inj. 3 Number Analyzed 468 participants 158 participants
1.5 8.9
2-11 years; Fever, Post-Inj. 1 Number Analyzed 236 participants 80 participants
8.1 6.3
2-11 years; Headache, Post-Inj. 1 Number Analyzed 236 participants 80 participants
25.0 16.3
2-11 years; Malaise, Post-Inj. 1 Number Analyzed 236 participants 80 participants
19.9 13.8
2-11 years; Myalgia, Post-Inj. 1 Number Analyzed 236 participants 80 participants
23.7 16.3
2-11 years; Asthenia, Post-Inj. 1 Number Analyzed 236 participants 80 participants
7.2 3.8
12-17 years; Fever, Post-Inj. 1 Number Analyzed 140 participants 46 participants
7.1 2.2
12-17 years; Headache, Post-Inj. 1 Number Analyzed 140 participants 46 participants
39.3 39.1
12-17 years; Malaise, Post-Inj. 1 Number Analyzed 140 participants 46 participants
29.3 17.4
12-17 years; Myalgia, Post-Inj. 1 Number Analyzed 140 participants 46 participants
32.1 23.9
12-17 years; Asthenia, Post-Inj. 1 Number Analyzed 140 participants 46 participants
13.6 6.5
18-45 years; Fever, Post-Inj. 1 Number Analyzed 515 participants 171 participants
2.3 1.2
18-45 years; Headache, Post-Inj. 1 Number Analyzed 515 participants 171 participants
29.7 29.2
18-45 years; Malaise, Post-Inj. 1 Number Analyzed 515 participants 171 participants
26.2 20.5
18-45 years; Myalgia, Post-Inj. 1 Number Analyzed 515 participants 171 participants
31.3 19.3
18-45 years; Asthenia, Post-Inj. 1 Number Analyzed 515 participants 171 participants
15.1 7.0
2-11 years; Fever, Post-Inj. 2 Number Analyzed 235 participants 76 participants
6.8 6.6
2-11 years; Headache, Post-Inj. 2 Number Analyzed 235 participants 76 participants
21.7 15.8
2-11 years; Malaise, Post-Inj. 2 Number Analyzed 235 participants 76 participants
21.7 13.2
2-11 years; Myalgia, Post-Inj. 2 Number Analyzed 235 participants 76 participants
24.7 22.4
2-11 years; Asthenia, Post-Inj. 2 Number Analyzed 235 participants 76 participants
7.7 7.9
12-17 years; Fever, Post-Inj. 2 Number Analyzed 136 participants 45 participants
4.4 0.0
12-17 years; Headache, Post-Inj. 2 Number Analyzed 136 participants 45 participants
19.9 22.2
12-17 years; Malaise, Post-Inj. 2 Number Analyzed 136 participants 45 participants
16.2 20.0
12-17 years; Myalgia, Post-Inj. 2 Number Analyzed 136 participants 45 participants
19.9 28.9
12-17 years; Asthenia, Post-Inj. 2 Number Analyzed 136 participants 45 participants
8.8 6.7
18-45 years; Fever, Post-Inj. 2 Number Analyzed 488 participants 164 participants
1.2 1.8
18-45 years; Headache, Post-Inj. 2 Number Analyzed 488 participants 164 participants
24.2 24.4
18-45 years; Malaise, Post-Inj. 2 Number Analyzed 488 participants 164 participants
18.6 20.1
18-45 years; Myalgia, Post-Inj. 2 Number Analyzed 488 participants 164 participants
24.8 32.9
18-45 years; Asthenia, Post-Inj. 2 Number Analyzed 488 participants 164 participants
10.2 12.2
2-11 years; Fever, Post-Inj. 3 Number Analyzed 233 participants 76 participants
8.2 6.6
2-11 years; Headache, Post-Inj. 3 Number Analyzed 233 participants 76 participants
17.6 11.8
2-11 years; Malaise, Post-Inj. 3 Number Analyzed 233 participants 76 participants
18.5 14.5
2-11 years; Myalgia, Post-Inj. 3 Number Analyzed 233 participants 76 participants
20.6 17.1
2-11 years; Asthenia, Post-Inj. 3 Number Analyzed 233 participants 76 participants
7.7 3.9
12-17 years; Fever, Post-Inj. 3 Number Analyzed 135 participants 44 participants
5.9 2.3
12-17 years; Headache, Post-Inj. 3 Number Analyzed 135 participants 44 participants
20.7 20.5
12-17 years; Malaise, Post-Inj. 3 Number Analyzed 135 participants 44 participants
18.5 18.2
12-17 years; Myalgia, Post-Inj. 3 Number Analyzed 135 participants 44 participants
14.8 25.0
12-17 years; Asthenia, Post-Inj. 3 Number Analyzed 135 participants 44 participants
5.9 11.4
18-45 years; Fever, Post-Inj. 3 Number Analyzed 468 participants 158 participants
2.8 1.3
18-45 years; Headache, Post-Inj. 3 Number Analyzed 468 participants 158 participants
21.2 23.4
18-45 years; Malaise, Post-Inj. 3 Number Analyzed 468 participants 158 participants
17.9 18.4
18-45 years; Myalgia, Post-Inj. 3 Number Analyzed 468 participants 158 participants
24.4 31.0
18-45 years; Asthenia, Post-Inj. 3 Number Analyzed 468 participants 158 participants
9.6 11.4
3.Primary Outcome
Title Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against each dengue virus serotype (parental strains) was assessed using a dengue plaque reduction neutralization test (PRNT) assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).
Time Frame Pre-Injection 1, 2, and 3 and 28 days Post-Injection 1, 2, and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Per-Protocol (PP) analysis set which included all participants who were vaccinated and had no protocol deviations. 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 the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 424 140
Measure Type: Number
Unit of Measure: Percentage of participants
CYD dengue Serotype 1; Pre-Injection 1 Number Analyzed 424 participants 140 participants
14.6 17.1
CYD dengue Serotype 1; Post-Injection 1 Number Analyzed 210 participants 69 participants
22.9 11.6
CYD dengue Serotype 1; Pre-Injection 2 Number Analyzed 183 participants 60 participants
30.1 16.7
CYD dengue Serotype 1; Post-Injection 2 Number Analyzed 184 participants 60 participants
54.9 18.3
CYD dengue Serotype 1; Pre-Injection 3 Number Analyzed 179 participants 58 participants
45.8 13.8
CYD dengue Serotype 1; Post-Injection 3 Number Analyzed 353 participants 101 participants
79.6 22.0
CYD dengue Serotype 2; Pre-Injection 1 Number Analyzed 422 participants 140 participants
16.1 15.0
CYD dengue Serotype 2; Post-Injection 1 Number Analyzed 210 participants 69 participants
39.5 10.1
CYD dengue Serotype 2; Pre-Injection 2 Number Analyzed 183 participants 60 participants
39.3 16.7
CYD dengue Serotype 2; Post-Injection 2 Number Analyzed 184 participants 60 participants
80.4 15.0
CYD dengue Serotype 2; Pre-Injection 3 Number Analyzed 180 participants 58 participants
58.3 13.8
CYD dengue Serotype 2; Post-Injection 3 Number Analyzed 353 participants 109 participants
88.1 20.2
CYD dengue Serotype 3; Pre-Injection 1 Number Analyzed 421 participants 139 participants
19.7 20.1
CYD dengue Serotype 3; Post-Injection 1 Number Analyzed 208 participants 69 participants
58.7 21.7
CYD dengue Serotype 3; Pre-Injection 2 Number Analyzed 183 participants 58 participants
63.9 31.0
CYD dengue Serotype 3; Post-Injection 2 Number Analyzed 183 participants 60 participants
87.4 26.7
CYD dengue Serotype 3; Pre-Injection 3 Number Analyzed 180 participants 58 participants
77.8 19.0
CYD dengue Serotype 3; Post-Injection 3 Number Analyzed 352 participants 109 participants
93.2 24.8
CYD dengue Serotype 4; Pre-Injection 1 Number Analyzed 421 participants 139 participants
12.8 12.9
CYD dengue Serotype 4; Post-Injection 1 Number Analyzed 208 participants 69 participants
67.3 11.6
CYD dengue Serotype 4; Pre-Injection 2 Number Analyzed 181 participants 60 participants
69.1 16.7
CYD dengue Serotype 4; Post-Injection 2 Number Analyzed 183 participants 59 participants
85.8 16.9
CYD dengue Serotype 4; Pre-Injection 3 Number Analyzed 179 participants 58 participants
79.3 8.6
CYD dengue Serotype 4; Post-Injection 3 Number Analyzed 351 participants 109 participants
93.7 19.3
4.Primary Outcome
Title Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against each dengue virus serotypes (parental strains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).
Time Frame Pre-Injection 1 and 28 days Post-Injection 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Per-Protocol analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 148 47
Measure Type: Number
Unit of Measure: Percentage of participants
2-11 years, CYD dengue Serotype 1; Pre-Inj. 1 Number Analyzed 148 participants 47 participants
4.7 8.5
2-11 years, CYD dengue Serotype 1; Post-Inj. 3 Number Analyzed 132 participants 37 participants
92.4 10.8
2-11 years, CYD dengue Serotype 2; Pre-Inj. 1 Number Analyzed 147 participants 47 participants
5.4 2.1
2-11 years, CYD dengue Serotype 2; Post-Inj. 3 Number Analyzed 132 participants 37 participants
93.9 16.2
2-11 years, CYD dengue Serotype 3; Pre-Inj. 1 Number Analyzed 147 participants 47 participants
11.6 10.6
2-11 years, CYD dengue Serotype 3; Post-Inj. 3 Number Analyzed 132 participants 37 participants
98.5 13.5
2-11 years, CYD dengue Serotype 4; Pre-Inj. 1 Number Analyzed 148 participants 47 participants
6.8 6.4
2-11 years, CYD dengue Serotype 4; Post-Inj. 3 Number Analyzed 131 participants 37 participants
96.9 18.9
12-17 years, CYD dengue Serotype 1; Pre-Inj. 1 Number Analyzed 140 participants 46 participants
5.7 4.3
12-17 years, CYD dengue Serotype 1; Post-Inj. 3 Number Analyzed 123 participants 38 participants
68.3 13.2
12-17 years, CYD dengue Serotype 2; Pre-Inj. 1 Number Analyzed 140 participants 46 participants
10.0 4.3
12-17 years, CYD dengue Serotype 2; Post-Inj. 3 Number Analyzed 123 participants 38 participants
87.0 10.5
12-17 years, CYD dengue Serotype 3; Pre-Inj. 1 Number Analyzed 139 participants 46 participants
11.5 10.9
12-17 years, CYD dengue Serotype 3; Post-Inj. 3 Number Analyzed 122 participants 38 participants
88.5 21.1
12-17 years, CYD dengue Serotype 4; Pre-Inj. 1 Number Analyzed 139 participants 46 participants
6.5 2.2
12-17 years, CYD dengue Serotype 4; Post-Inj. 3 Number Analyzed 123 participants 38 participants
91.1 10.5
18-45 years, CYD dengue Serotype 1; Pre-Inj. 1 Number Analyzed 136 participants 47 participants
34.6 38.3
18-45 years, CYD dengue Serotype 1; Post-Inj. 3 Number Analyzed 98 participants 34 participants
76.5 44.1
18-45 years, CYD dengue Serotype 2; Pre-Inj. 1 Number Analyzed 135 participants 47 participants
34.1 38.3
18-45 years, CYD dengue Serotype 2; Post-Inj. 3 Number Analyzed 98 participants 34 participants
81.6 35.3
18-45 years, CYD dengue Serotype 3; Pre-Inj. 1 Number Analyzed 135 participants 46 participants
37.0 39.1
18-45 years, CYD dengue Serotype 3; Post-Inj. 3 Number Analyzed 98 participants 34 participants
91.8 41.2
18-45 years, CYD dengue Serotype 4; Pre-Inj. 1 Number Analyzed 134 participants 46 participants
26.1 30.4
18-45 years, CYD dengue Serotype 4; Post-Inj. 3 Number Analyzed 97 participants 34 participants
92.8 29.4
5.Primary Outcome
Title Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes (parental strains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).
Time Frame Pre-Injection 1 and 28 days Post-Injection 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Per-Protocol analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 148 47
Measure Type: Number
Unit of Measure: Percentage of participants
2-11 yrs, CYD dengue >=1 serotype; Pre- Inj. 1 Number Analyzed 148 participants 47 participants
19.6 27.7
2-11 yrs, CYD dengue >=1 serotype; Post-Inj. 3 Number Analyzed 132 participants 37 participants
100 56.8
2-11 yrs, CYD dengue >=2 serotypes; Pre-Inj. 1 Number Analyzed 148 participants 47 participants
6.1 0.0
2-11 yrs, CYD dengue >=2 serotypes; Post-Inj. 3 Number Analyzed 132 participants 37 participants
99.2 2.7
2-11 yrs, CYD dengue >=3 serotypes; Pre-Inj. 1 Number Analyzed 148 participants 47 participants
2.0 0.0
2-11 yrs, CYD dengue >=3 serotypes; Post-Inj. 3 Number Analyzed 132 participants 37 participants
97.0 0.0
2-11 yrs, CYD dengue All 4 serotypes; Pre-Inj. 1 Number Analyzed 148 participants 47 participants
0.7 0.0
2-11 yrs, CYD dengue All 4 serotypes; Post-Inj. 3 Number Analyzed 132 participants 37 participants
84.8 0.0
12-17 yrs, CYD dengue >=1 serotype; Pre-Inj. 1 Number Analyzed 140 participants 46 participants
13.6 15.2
12-17 yrs, CYD dengue >=1 serotype; Post-Inj. 3 Number Analyzed 123 participants 38 participants
98.4 26.3
12-17 yrs, CYD dengue >=2 serotypes; Pre-Inj. 1 Number Analyzed 140 participants 46 participants
7.9 4.3
12-17 yrs, CYD dengue >=2 serotypes; Post-Inj. 3 Number Analyzed 123 participants 38 participants
95.1 10.5
12-17 yrs, CYD dengue >=3 serotypes; Pre-Inj. 1 Number Analyzed 140 participants 46 participants
7.1 2.2
12-17 yrs, CYD dengue >=3 serotypes; Post-Inj. 3 Number Analyzed 123 participants 38 participants
81.3 10.5
12-17 yrs, CYD dengue All 4 serotypes; Pre-Inj. 1 Number Analyzed 140 participants 46 participants
5.0 0.0
12-17 yrs, CYD dengue All 4 serotypes; Post-Inj. 3 Number Analyzed 123 participants 38 participants
59.3 7.9
18-45 yrs, CYD dengue >=1 serotype; Pre-Inj. 1 Number Analyzed 136 participants 47 participants
47.1 53.2
18-45 yrs, CYD dengue >=1 serotype; Post-Inj. 3 Number Analyzed 98 participants 34 participants
100 55.9
18-45 yrs, CYD dengue >=2 serotypes; Pre-Inj. 1 Number Analyzed 136 participants 47 participants
33.8 38.3
18-45 yrs, CYD dengue >=2 serotypes; Post-Inj. 3 Number Analyzed 98 participants 34 participants
96.9 35.3
18-45 yrs, CYD dengue >=3 serotypes; Pre-Inj. 1 Number Analyzed 136 participants 47 participants
27.9 31.9
18-45 yrs, CYD dengue >=3 serotypes; Post-Inj. 3 Number Analyzed 98 participants 34 participants
83.7 32.4
18-45 yrs, CYD dengue All 4 serotypes; Pre-Inj. 1 Number Analyzed 136 participants 47 participants
22.1 21.3
18-45 yrs, CYD dengue All 4 serotypes; Post-Inj. 3 Number Analyzed 98 participants 34 participants
61.2 26.5
6.Primary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
Hide Description GMTs against each serotype with the parental dengue virus strains were assessed using a dengue PRNT assay.
Time Frame Pre-Injection 1, 2, and 3 and 28 days Post-Injection 1, 2, and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Per-Protocol 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 the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 424 140
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
CYD dengue Serotype 1; Pre-Injection 1 Number Analyzed 424 participants 140 participants
8.20
(7.20 to 9.33)
8.23
(6.62 to 10.2)
CYD dengue Serotype 1; Post-Injection 1 Number Analyzed 210 participants 69 participants
10.0
(8.06 to 12.4)
7.09
(5.48 to 9.18)
CYD dengue Serotype 1; Pre-Injection 2 Number Analyzed 183 participants 60 participants
12.9
(9.89 to 16.7)
7.85
(5.79 to 10.6)
CYD dengue Serotype 1; Post-Injection 2 Number Analyzed 184 participants 60 participants
22.4
(17.1 to 29.3)
7.91
(5.85 to 10.7)
CYD dengue Serotype 1; Pre-Injection 3 Number Analyzed 179 participants 58 participants
18.0
(14.0 to 23.2)
7.40
(5.54 to 9.88)
CYD dengue Serotype 1; Post-Injection 3 Number Analyzed 353 participants 109 participants
46.6
(39.0 to 55.6)
8.93
(7.08 to 11.3)
CYD dengue Serotype 2; Pre-Injection 1 Number Analyzed 422 participants 140 participants
9.06
(7.86 to 10.4)
8.48
(6.69 to 10.8)
CYD dengue Serotype 2; Post-Injection 1 Number Analyzed 210 participants 69 participants
17.2
(13.3 to 22.2)
7.39
(5.49 to 9.94)
CYD dengue Serotype 2; Pre-Injection 2 Number Analyzed 183 participants 60 participants
19.1
(14.3 to 25.5)
9.79
(6.45 to 14.9)
CYD dengue Serotype 2; Post-Injection 2 Number Analyzed 184 participants 60 participants
50.3
(39.0 to 65.0)
9.48
(6.22 to 14.4)
CYD dengue Serotype 2; Pre-Injection 3 Number Analyzed 180 participants 58 participants
24.4
(19.2 to 31.1)
6.98
(5.38 to 9.07)
CYD dengue Serotype 2; Post-Injection 3 Number Analyzed 353 participants 109 participants
72.7
(61.6 to 85.8)
8.88
(6.90 to 11.4)
CYD dengue Serotype 3; Pre-Injection 1 Number Analyzed 421 participants 139 participants
8.45
(7.54 to 9.47)
8.93
(7.11 to 11.2)
CYD dengue Serotype 3; Post-Injection 1 Number Analyzed 208 participants 69 participants
28.2
(22.0 to 36.3)
9.56
(6.72 to 13.6)
CYD dengue Serotype 3; Pre-Injection 2 Number Analyzed 183 participants 58 participants
29.7
(23.2 to 38.0)
11.1
(7.60 to 16.3)
CYD dengue Serotype 3; Post-Injection 2 Number Analyzed 183 participants 60 participants
70.8
(56.8 to 88.2)
10.5
(7.36 to 14.9)
CYD dengue Serotype 3; Pre-Injection 3 Number Analyzed 180 participants 58 participants
39.1
(31.2 to 48.9)
8.23
(5.88 to 11.5)
CYD dengue Serotype 3; Post-Injection 3 Number Analyzed 352 participants 109 participants
100
(86.9 to 116)
9.52
(7.41 to 12.2)
CYD dengue Serotype 4; Pre-Injection 1 Number Analyzed 421 participants 139 participants
6.93
(6.31 to 7.60)
6.84
(5.86 to 7.99)
CYD dengue Serotype 4; Post-Injection 1 Number Analyzed 208 participants 69 participants
65.9
(49.1 to 88.3)
6.31
(5.30 to 7.50)
CYD dengue Serotype 4; Pre-Injection 2 Number Analyzed 181 participants 60 participants
47.5
(36.5 to 61.8)
7.91
(5.91 to 10.6)
CYD dengue Serotype 4; Post-Injection 2 Number Analyzed 183 participants 59 participants
90.2
(71.7 to 114)
8.00
(5.89 to 10.9)
CYD dengue Serotype 4; Pre-Injection 3 Number Analyzed 179 participants 58 participants
47.1
(37.9 to 58.5)
6.04
(5.09 to 7.17)
CYD dengue Serotype 4; Post-Injection 3 Number Analyzed 351 participants 109 participants
99.4
(87.4 to 113)
7.66
(6.35 to 9.24)
7.Primary Outcome
Title GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
Hide Description GMTs against each dengue virus serotype (parental strains) were assessed using a dengue PRNT assay.
Time Frame Pre-Injection 1 and 28 days Post-Injection 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Per-Protocol analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 148 47
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
2-11 years, CYD dengue Serotype 1; Pre-Inj. 1 Number Analyzed 148 participants 47 participants
5.33
(5.08 to 5.6)
5.44
(5.01 to 5.92)
2-11 years, CYD dengue Serotype 1; Post-Inj. 3 Number Analyzed 132 participants 37 participants
60.7
(49.5 to 74.3)
6.32
(4.92 to 8.13)
2-11 years, CYD dengue Serotype 2; Pre-Inj. 1 Number Analyzed 147 participants 47 participants
5.85
(5.18 to 6.60)
5.18
(4.82 to 5.57)
2-11 years, CYD dengue Serotype 2; Post-Inj. 3 Number Analyzed 132 participants 37 participants
95.9
(76.7 to 120)
6.09
(5.18 to 7.16)
2-11 years, CYD dengue Serotype 3; Pre-Inj. 1 Number Analyzed 147 participants 47 participants
6.24
(5.57 to 6.99)
6.02
(5.04 to 7.17)
2-11 years, CYD dengue Serotype 3; Post-Inj. 3 Number Analyzed 132 participants 37 participants
138
(115 to 165)
6.67
(5.11 to 8.71)
2-11 years, CYD dengue Serotype 4; Pre-Inj. 1 Number Analyzed 148 participants 47 participants
5.64
(5.20 to 6.11)
5.42
(4.92 to 5.97)
2-11 years, CYD dengue Serotype 4; Post-Inj. 3 Number Analyzed 131 participants 37 participants
101
(84.6 to 122)
6.92
(5.47 to 8.76)
12-17 years, CYD dengue Serotype 1; Pre-Inj. 1 Number Analyzed 140 participants 46 participants
6.49
(5.31 to 7.92)
5.47
(4.80 to 6.24)
12-17 years, CYD dengue Serotype 1; Post-Inj. 3 Number Analyzed 123 participants 38 participants
28.9
(21.5 to 38.7)
6.56
(5.14 to 8.37)
12-17 years, CYD dengue Serotype 2; Pre-Inj. 1 Number Analyzed 140 participants 46 participants
7.47
(5.96 to 9.37)
5.54
(4.69 to 6.56)
12-17 years, CYD dengue Serotype 2; Post-Inj. 3 Number Analyzed 123 participants 38 participants
54.0
(41.1 to 70.9)
6.35
(5.03 to 8.00)
12-17 years, CYD dengue Serotype 3; Pre-Inj. 1 Number Analyzed 139 participants 46 participants
6.86
(5.82 to 8.09)
6.83
(4.84 to 9.65)
12-17 years, CYD dengue Serotype 3; Post-Inj. 3 Number Analyzed 122 participants 38 participants
74.1
(57.5 to 95.5)
8.32
(5.57 to 12.4)
12-17 years, CYD dengue Serotype 4; Pre-Inj. 1 Number Analyzed 139 participants 46 participants
5.83
(5.18 to 6.57)
5.08
(4.92 to 5.23)
12-17 years, CYD dengue Serotype 4; Post-Inj. 3 Number Analyzed 123 participants 38 participants
80.4
(64.2 to 101)
6.68
(4.87 to 9.15)
18-45 years, CYD dengue Serotype 1; Pre-Inj. 1 Number Analyzed 136 participants 47 participants
16.7
(12.2 to 22.8)
18.5
(10.4 to 32.9)
18-45 years, CYD dengue Serotype 1; Post-Inj. 3 Number Analyzed 98 participants 34 participants
59.5
(38.7 to 91.6)
18.3
(10.2 to 33.0)
18-45 years, CYD dengue Serotype 2; Pre-Inj. 1 Number Analyzed 135 participants 47 participants
17.8
(12.8 to 24.7)
21.1
(11.3 to 39.2)
18-45 years, CYD dengue Serotype 2; Post-Inj. 3 Number Analyzed 98 participants 34 participants
72.7
(49.4 to 107)
19.5
(9.69 to 39.1)
18-45 years, CYD dengue Serotype 3; Pre-Inj. 1 Number Analyzed 135 participants 46 participants
14.6
(11.2 to 19)
17.5
(10.2 to 30.0)
18-45 years, CYD dengue Serotype 3; Post-Inj. 3 Number Analyzed 98 participants 34 participants
94.9
(69.4 to 130)
16.3
(9.06 to 29.4)
18-45 years, CYD dengue Serotype 4; Pre-Inj. 1 Number Analyzed 134 participants 46 participants
10.4
(8.22 to 13.2)
11.7
(7.65 to 17.9)
18-45 years, CYD dengue Serotype 4; Post-Inj. 3 Number Analyzed 97 participants 34 participants
127
(96 to 167)
9.96
(6.47 to 15.3)
8.Secondary Outcome
Title Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against each dengue virus serotypes (parental strains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).
Time Frame Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included participants who received at least 1 dose of CYD dengue vaccine or Placebo, had at least 1 blood sample drawn and valid post-vaccination serology result. Here, ‘overall number of participants analyzed’=participants evaluable for outcome measure and ‘number analyzed’=participants with available data for specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 236 80
Measure Type: Number
Unit of Measure: Percentage of participants
CYD dengue Serotype 1; Pre-Injection 1 Number Analyzed 148 participants 50 participants
4.7 8.0
CYD dengue Serotype 1; Post-Injection 3 Number Analyzed 144 participants 45 participants
91.0 8.9
CYD dengue Serotype 1; 1st year follow up Number Analyzed 141 participants 44 participants
41.8 6.8
CYD dengue Serotype 1; 2nd year follow up Number Analyzed 140 participants 43 participants
27.1 0.0
CYD dengue Serotype 1; 3rd year follow up Number Analyzed 133 participants 43 participants
16.5 0.0
CYD dengue Serotype 1; 4th year follow up Number Analyzed 136 participants 42 participants
9.6 0.0
CYD dengue Serotype 2; Pre-Injection 1 Number Analyzed 147 participants 50 participants
5.4 2.0
CYD dengue Serotype 2; Post-Injection 3 Number Analyzed 144 participants 45 participants
94.4 13.3
CYD dengue Serotype 2; 1st year follow up Number Analyzed 141 participants 45 participants
59.6 8.9
CYD dengue Serotype 2; 2nd year follow up Number Analyzed 140 participants 43 participants
52.1 11.6
CYD dengue Serotype 2; 3rd year follow up Number Analyzed 134 participants 43 participants
34.3 7.0
CYD dengue Serotype 2; 4th year follow up Number Analyzed 130 participants 42 participants
36.9 2.4
CYD dengue Serotype 3; Pre-Injection 1 Number Analyzed 147 participants 50 participants
11.6 10.0
CYD dengue Serotype 3; Post-Injection 3 Number Analyzed 144 participants 44 participants
97.9 13.6
CYD dengue Serotype 3; 1st year follow up Number Analyzed 141 participants 44 participants
66.0 9.1
CYD dengue Serotype 3; 2nd year follow up Number Analyzed 133 participants 41 participants
74.4 29.3
CYD dengue Serotype 3; 3rd year follow up Number Analyzed 134 participants 43 participants
50.0 4.7
CYD dengue Serotype 3; 4th year follow up Number Analyzed 130 participants 42 participants
37.7 2.4
CYD dengue Serotype 4; Pre-Injection 1 Number Analyzed 148 participants 50 participants
6.8 6.0
CYD dengue Serotype 4; Post-Injection 3 Number Analyzed 143 participants 44 participants
97.2 20.5
CYD dengue Serotype 4; 1st year follow up Number Analyzed 141 participants 43 participants
75.2 4.7
CYD dengue Serotype 4; 2nd year follow up Number Analyzed 140 participants 43 participants
72.9 4.7
CYD dengue Serotype 4; 3rd year follow up Number Analyzed 132 participants 43 participants
60.6 7.0
CYD dengue Serotype 4; 4th year follow up Number Analyzed 136 participants 42 participants
49.3 0.0
9.Secondary Outcome
Title Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against each dengue virus serotypes (parental stains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with antibody titers >=10 (1/dilution).
Time Frame Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 141 46
Measure Type: Number
Unit of Measure: Percentage of participants
CYD dengue Serotype 1; Pre-Injection 1 Number Analyzed 141 participants 46 participants
5.7 4.3
CYD dengue Serotype 1; Post-Injection 3 Number Analyzed 135 participants 43 participants
67.4 11.6
CYD dengue Serotype 1; 1st year follow up Number Analyzed 132 participants 41 participants
25.8 7.3
CYD dengue Serotype 1; 2nd year follow up Number Analyzed 128 participants 40 participants
19.5 7.5
CYD dengue Serotype 1; 3rd year follow up Number Analyzed 124 participants 40 participants
16.1 5.0
CYD dengue Serotype 1; 4th year follow up Number Analyzed 118 participants 37 participants
11.9 5.4
CYD dengue Serotype 2; Pre-Injection 1 Number Analyzed 141 participants 46 participants
9.9 4.3
CYD dengue Serotype 2; Post-Injection 3 Number Analyzed 135 participants 43 participants
83.7 9.3
CYD dengue Serotype 2; 1st year follow up Number Analyzed 131 participants 41 participants
44.3 4.9
CYD dengue Serotype 2; 2nd year follow up Number Analyzed 128 participants 40 participants
52.3 10.0
CYD dengue Serotype 2; 3rd year follow up Number Analyzed 124 participants 40 participants
35.5 5.0
CYD dengue Serotype 2; 4th year follow up Number Analyzed 116 participants 37 participants
36.2 5.4
CYD dengue Serotype 3; Pre-Injection 1 Number Analyzed 140 participants 46 participants
11.4 10.9
CYD dengue Serotype 3; Post-Injection 3 Number Analyzed 134 participants 43 participants
88.8 20.9
CYD dengue Serotype 3; 1st year follow up Number Analyzed 133 participants 40 participants
61.7 5.0
CYD dengue Serotype 3; 2nd year follow up Number Analyzed 126 participants 40 participants
56.3 12.5
CYD dengue Serotype 3; 3rd year follow up Number Analyzed 123 participants 40 participants
48.8 5.0
CYD dengue Serotype 3; 4th year follow up Number Analyzed 118 participants 37 participants
47.5 5.4
CYD dengue Serotype 4; Pre-Injection 1 Number Analyzed 140 participants 46 participants
6.4 2.2
CYD dengue Serotype 4; Post-Injection 3 Number Analyzed 135 participants 43 participants
91.1 9.3
CYD dengue Serotype 4; 1st year follow up Number Analyzed 132 participants 41 participants
73.5 2.4
CYD dengue Serotype 4; 2nd year follow up Number Analyzed 128 participants 40 participants
71.1 10.0
CYD dengue Serotype 4; 3rd year follow up Number Analyzed 123 participants 40 participants
66.7 5.0
CYD dengue Serotype 4; 4th year follow up Number Analyzed 118 participants 37 participants
61.0 8.1
10.Secondary Outcome
Title Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against each dengue virus serotypes (parental stains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).
Time Frame Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 521 174
Measure Type: Number
Unit of Measure: Percentage of participants
CYD dengue Serotype 1; Pre-Injection 1 Number Analyzed 142 participants 49 participants
33.1 38.8
CYD dengue Serotype 1; Post-Injection 3 Number Analyzed 127 participants 43 participants
71.7 39.5
CYD dengue Serotype 1; 1st year follow up Number Analyzed 122 participants 44 participants
45.9 31.8
CYD dengue Serotype 1; 2nd year follow up Number Analyzed 117 participants 41 participants
43.6 34.1
CYD dengue Serotype 1; 3rd year follow up Number Analyzed 114 participants 39 participants
40.4 30.8
CYD dengue Serotype 1; 4th year follow up Number Analyzed 106 participants 38 participants
39.6 31.6
CYD dengue Serotype 2; Pre-Injection 1 Number Analyzed 141 participants 49 participants
32.6 38.8
CYD dengue Serotype 2; Post-Injection 3 Number Analyzed 127 participants 43 participants
80.3 30.2
CYD dengue Serotype 2; 1st year follow up Number Analyzed 122 participants 44 participants
66.4 40.9
CYD dengue Serotype 2; 2nd year follow up Number Analyzed 117 participants 41 participants
68.4 34.1
CYD dengue Serotype 2; 3rd year follow up Number Analyzed 114 participants 39 participants
55.3 35.9
CYD dengue Serotype 2; 4th year follow up Number Analyzed 105 participants 38 participants
55.2 31.6
CYD dengue Serotype 3; Pre-Injection 1 Number Analyzed 141 participants 48 participants
36.9 41.7
CYD dengue Serotype 3; Post-Injection 3 Number Analyzed 127 participants 43 participants
92.9 34.9
CYD dengue Serotype 3; 1st year follow up Number Analyzed 121 participants 44 participants
68.6 38.6
CYD dengue Serotype 3; 2nd year follow up Number Analyzed 117 participants 41 participants
77.8 46.3
CYD dengue Serotype 3; 3rd year follow up Number Analyzed 112 participants 39 participants
67.9 35.9
CYD dengue Serotype 3; 4th year follow up Number Analyzed 106 participants 37 participants
56.6 29.7
CYD dengue Serotype 4; Pre-Injection 1 Number Analyzed 140 participants 48 participants
25.0 31.3
CYD dengue Serotype 4; Post-Injection 3 Number Analyzed 126 participants 43 participants
93.7 32.6
CYD dengue Serotype 4; 1st year follow up Number Analyzed 122 participants 44 participants
86.9 29.5
CYD dengue Serotype 4; 2nd year follow up Number Analyzed 117 participants 41 participants
81.2 24.4
CYD dengue Serotype 4; 3rd year follow up Number Analyzed 114 participants 39 participants
79.8 20.5
CYD dengue Serotype 4; 4th year follow up Number Analyzed 107 participants 38 participants
77.6 21.1
11.Secondary Outcome
Title Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).
Time Frame Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 236 80
Measure Type: Number
Unit of Measure: Percentage of participants
CYD dengue >=1 serotype; Pre-Injection 1 Number Analyzed 148 participants 50 participants
19.6 26.0
CYD dengue >=1 serotype; Post-Injection 3 Number Analyzed 144 participants 45 participants
100.0 51.1
CYD dengue >=1 serotype; 1st year follow up Number Analyzed 142 participants 45 participants
92.3 20.0
CYD dengue >=1 serotype; 2nd year follow up Number Analyzed 140 participants 43 participants
95.0 34.9
CYD dengue >=1 serotype; 3rd year follow up Number Analyzed 134 participants 43 participants
76.9 7.0
CYD dengue >=1 serotype; 4th year follow up Number Analyzed 136 participants 42 participants
72.1 4.8
CYD dengue >=2 serotypes; Pre-Injection 1 Number Analyzed 148 participants 50 participants
6.1 0.0
CYD dengue >=2 serotypes; Post- Injection 3 Number Analyzed 144 participants 45 participants
99.3 4.4
CYD dengue >=2 serotypes; 1st year follow up Number Analyzed 142 participants 45 participants
66.2 6.7
CYD dengue >=2 serotypes; 2nd year follow up Number Analyzed 140 participants 43 participants
70.7 9.3
CYD dengue >=2 serotypes; 3rd year follow up Number Analyzed 134 participants 43 participants
48.5 7.0
CYD dengue >=2 serotypes; 4th year follow up Number Analyzed 136 participants 42 participants
35.3 0.0
CYD dengue >=3 serotypes; Pre-Injection 1 Number Analyzed 148 participants 50 participants
2.0 0.0
CYD dengue >=3 serotypes; Post- Injection 3 Number Analyzed 144 participants 45 participants
96.5 0.0
CYD dengue >=3 serotypes; 1st year follow up Number Analyzed 142 participants 45 participants
52.8 2.2
CYD dengue >=3 serotypes; 2nd year follow up Number Analyzed 140 participants 43 participants
42.1 0.0
CYD dengue >=3 serotypes; 3rd year follow up Number Analyzed 134 participants 43 participants
23.9 4.7
CYD dengue >=3 serotypes; 4th year follow up Number Analyzed 136 participants 42 participants
16.2 0.0
CYD dengue All 4 serotypes; Pre- Injection 1 Number Analyzed 148 participants 50 participants
0.7 0.0
CYD dengue All 4 serotypes; Post- Injection 3 Number Analyzed 144 participants 45 participants
84.0 0.0
CYD dengue All 4 serotypes; 1st year follow up Number Analyzed 142 participants 45 participants
29.6 0.0
CYD dengue All 4 serotypes; 2nd year follow up Number Analyzed 140 participants 43 participants
15.0 0.0
CYD dengue All 4 serotypes; 3rd year follow up Number Analyzed 134 participants 43 participants
11.2 0.0
CYD dengue All 4 serotypes; 4th year follow up Number Analyzed 136 participants 42 participants
6.6 0.0
12.Secondary Outcome
Title Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).
Time Frame Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 141 46
Measure Type: Number
Unit of Measure: Percentage of participants
CYD dengue >=1 Serotype; Pre-Injection 1 Number Analyzed 141 participants 46 participants
13.5 15.2
CYD dengue >=1 Serotype; Post- Injection 3 Number Analyzed 135 participants 43 participants
97.8 25.6
CYD dengue >=1 Serotype; 1st year follow up Number Analyzed 133 participants 41 participants
94.7 7.3
CYD dengue >=1 Serotype; 2nd year follow up Number Analyzed 128 participants 40 participants
93.0 15.0
CYD dengue >=1 Serotype; 3rd year follow up Number Analyzed 124 participants 40 participants
89.5 5.0
CYD dengue >=1 serotype; 4th year follow up Number Analyzed 118 participants 37 participants
81.4 8.1
CYD dengue >=2 Serotypes; Pre- Injection 1 Number Analyzed 141 participants 46 participants
7.8 4.3
CYD dengue >=2 Serotypes; Post- Injection 3 Number Analyzed 135 participants 43 participants
94.8 9.3
CYD dengue >=2 Serotypes; 1st year follow up Number Analyzed 133 participants 41 participants
60.2 4.9
CYD dengue >=2 Serotypes; 2nd year follow up Number Analyzed 128 participants 40 participants
62.5 10.0
CYD dengue >=2 Serotypes; 3rd year follow up Number Analyzed 124 participants 40 participants
45.2 5.0
CYD dengue >=2 serotypes; 4th year follow up Number Analyzed 118 participants 37 participants
44.9 5.4
CYD dengue >=3 Serotypes; Pre- Injection 1 Number Analyzed 141 participants 46 participants
7.1 2.2
CYD dengue >=3 Serotypes; Post- Injection 3 Number Analyzed 135 participants 43 participants
80.7 9.3
CYD dengue >=3 Serotypes; 1st year follow up Number Analyzed 133 participants 41 participants
33.1 4.9
CYD dengue >=3 Serotypes; 2nd year follow up Number Analyzed 128 participants 40 participants
31.3 7.5
CYD dengue >=3 Serotypes; 3rd year follow up Number Analyzed 124 participants 40 participants
22.6 5.0
CYD dengue >=3 serotypes; 4th year follow up Number Analyzed 118 participants 37 participants
20.3 5.4
CYD dengue All 4 Serotypes; Pre- Injection 1 Number Analyzed 141 participants 46 participants
5.0 0.0
CYD dengue All 4 Serotypes; Post- Injection 3 Number Analyzed 135 participants 43 participants
57.0 7.0
CYD dengue All 4 Serotypes; 1st year follow up Number Analyzed 133 participants 41 participants
15.8 2.4
CYD dengue All 4 Serotypes; 2nd year follow up Number Analyzed 128 participants 40 participants
11.7 7.5
CYD dengue All 4 Serotypes; 3rd year follow up Number Analyzed 124 participants 40 participants
8.9 5.0
CYD dengue All 4 serotypes; 4th year follow up Number Analyzed 118 participants 37 participants
9.3 5.4
13.Secondary Outcome
Title Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution).
Time Frame Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 521 174
Measure Type: Number
Unit of Measure: Percentage of participants
CYD dengue >=1 Serotype; Pre-Injection 1 Number Analyzed 142 participants 49 participants
46.5 55.1
CYD dengue >=1 Serotype; Post- Injection 3 Number Analyzed 127 participants 43 participants
100.0 53.5
CYD dengue >=1 Serotype; 1st year follow up Number Analyzed 122 participants 44 participants
96.7 50.0
CYD dengue >=1 Serotype; 2nd year follow up Number Analyzed 117 participants 41 participants
96.6 56.1
CYD dengue >=1 Serotype; 3rd year follow up Number Analyzed 114 participants 39 participants
93.0 41.0
CYD dengue >=1 serotype; 4th year follow up Number Analyzed 107 participants 38 participants
92.5 36.8
CYD dengue >=2 Serotypes; Pre- Injection 1 Number Analyzed 142 participants 49 participants
32.4 38.8
CYD dengue >=2 Serotypes; Post- Injection 3 Number Analyzed 127 participants 43 participants
97.6 32.6
CYD dengue >=2 Serotypes; 1st year follow up Number Analyzed 122 participants 44 participants
73.8 38.6
CYD dengue >=2 Serotypes; 2nd year follow up Number Analyzed 117 participants 41 participants
76.9 34.1
CYD dengue >=2 Serotypes; 3rd year follow up Number Analyzed 114 participants 39 participants
63.2 33.3
CYD dengue >=2 serotypes; 4th year follow up Number Analyzed 107 participants 38 participants
54.2 28.9
CYD dengue >=3 Serotypes; Pre- Injection 1 Number Analyzed 142 participants 49 participants
26.8 32.7
CYD dengue >=3 Serotypes; Post- Injection 3 Number Analyzed 127 participants 43 participants
83.5 27.9
CYD dengue >=3 Serotypes; 1st year follow up Number Analyzed 122 participants 44 participants
55.7 34.1
CYD dengue >=3 Serotypes; 2nd year follow up Number Analyzed 117 participants 41 participants
56.4 29.3
CYD dengue >=3 Serotypes; 3rd year follow up Number Analyzed 114 participants 39 participants
46.5 30.8
CYD dengue >=3 serotypes; 4th year follow up Number Analyzed 107 participants 38 participants
43.0 26.3
CYD dengue All 4 Serotypes; Pre- Injection 1 Number Analyzed 142 participants 49 participants
21.1 22.4
CYD dengue All 4 Serotypes; Post- Injection 3 Number Analyzed 127 participants 43 participants
56.7 23.3
CYD dengue All 4 Serotypes; 1st year follow up Number Analyzed 122 participants 44 participants
41.0 18.2
CYD dengue All 4 Serotypes; 2nd year follow up Number Analyzed 117 participants 41 participants
41.0 19.5
CYD dengue All 4 Serotypes; 3rd year follow up Number Analyzed 114 participants 39 participants
39.5 17.9
CYD dengue All 4 serotypes; 4th year follow up Number Analyzed 107 participants 38 participants
37.4 21.1
14.Secondary Outcome
Title GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
Hide Description GMTs against each serotype with the dengue virus strain (parental strains) were assessed using a dengue PRNT assay.
Time Frame Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 236 80
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
CYD dengue Serotype 1; Pre-Injection 1 Number Analyzed 148 participants 50 participants
5.33
(5.08 to 5.60)
5.42
(5 to 5.86)
CYD dengue Serotype 1; Post-Injection 3 Number Analyzed 144 participants 45 participants
56.6
(46.5 to 68.9)
6.06
(4.93 to 7.46)
CYD dengue Serotype 1; 1st year follow up Number Analyzed 141 participants 44 participants
12.1
(9.92 to 14.7)
5.52
(4.92 to 6.19)
CYD dengue Serotype 1; 2nd year follow up Number Analyzed 140 participants 43 participants
8.89
(7.5 to 10.5)
5.00
(5.00 to 5.00)
CYD dengue Serotype 1; 3rd year follow up Number Analyzed 133 participants 43 participants
7.35
(6.22 to 8.67)
5.00
(5.00 to 5.00)
CYD dengue Serotype 1; 4th year follow up Number Analyzed 136 participants 42 participants
6.21
(5.51 to 7.00)
5.00
(5.00 to 5.00)
CYD dengue Serotype 2; Pre-Injection 1 Number Analyzed 147 participants 50 participants
5.85
(5.18 to 6.60)
5.17
(4.83 to 5.53)
CYD dengue Serotype 2; Post-Injection 3 Number Analyzed 144 participants 45 participants
101
(81.7 to 125)
5.88
(5.15 to 6.72)
CYD dengue Serotype 2; 1st year follow up Number Analyzed 141 participants 45 participants
21.1
(16.6 to 26.9)
5.86
(4.79 to 7.16)
CYD dengue Serotype 2; 2nd year follow up Number Analyzed 140 participants 43 participants
16.4
(12.9 to 20.9)
6.11
(5.10 to 7.32)
CYD dengue Serotype 2; 3rd year follow up Number Analyzed 134 participants 43 participants
11.7
(9.10 to 15.1)
5.58
(4.86 to 6.41)
CYD dengue Serotype 2; 4th year follow up Number Analyzed 130 participants 42 participants
14.2
(10.7 to 19.0)
5.11
(4.89 to 5.32)
CYD dengue Serotype 3; Pre-Injection 1 Number Analyzed 147 participants 50 participants
6.24
(5.57 to 6.99)
5.95
(5.04 to 7.02)
CYD dengue Serotype 3; Post-Injection 3 Number Analyzed 144 participants 44 participants
136
(114 to 162)
6.54
(5.20 to 8.22)
CYD dengue Serotype 3; 1st year follow up Number Analyzed 141 participants 44 participants
25.4
(20.1 to 32.1)
5.87
(5.00 to 6.89)
CYD dengue Serotype 3; 2nd year follow up Number Analyzed 133 participants 41 participants
29.9
(23.4 to 38.1)
10.1
(6.68 to 15.20)
CYD dengue Serotype 3; 3rd year follow up Number Analyzed 134 participants 43 participants
14.6
(11.7 to 18.3)
5.43
(4.83 to 6.10)
CYD dengue Serotype 3; 4th year follow up Number Analyzed 130 participants 42 participants
11.4
(9.22 to 14.10)
5.09
(4.91 to 5.29)
CYD dengue Serotype 4; Pre-Injection 1 Number Analyzed 148 participants 50 participants
5.64
(5.20 to 6.11)
5.39
(4.92 to 5.91)
CYD dengue Serotype 4; Post-Injection 3 Number Analyzed 143 participants 44 participants
104
(87.2 to 125)
7.20
(5.74 to 9.05)
CYD dengue Serotype 4; 1st year follow up Number Analyzed 141 participants 43 participants
31.8
(25.6 to 39.6)
5.69
(4.70 to 6.89)
CYD dengue Serotype 4; 2nd year follow up Number Analyzed 140 participants 43 participants
30.6
(24.2 to 38.6)
5.68
(4.74 to 6.82)
CYD dengue Serotype 4; 3rd year follow up Number Analyzed 132 participants 43 participants
22.3
(17.5 to 28.5)
6.31
(4.84 to 8.24)
CYD dengue Serotype 4; 4th year follow up Number Analyzed 136 participants 42 participants
16.5
(13.1 to 20.7)
5.00
(5.00 to 5.00)
15.Secondary Outcome
Title GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
Hide Description GMTs against each serotype with the dengue virus strain (parental strains) were assessed using a dengue PRNT assay.
Time Frame Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 141 46
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
CYD dengue Serotype 1; Pre-Injection 1 Number Analyzed 141 participants 46 participants
6.47
(5.31 to 7.89)
5.47
(4.80 to 6.24)
CYD dengue Serotype 1; Post-Injection 3 Number Analyzed 135 participants 43 participants
28.5
(21.4 to 37.9)
6.36
(5.12 to 7.89)
CYD dengue Serotype 1; 1st year follow up Number Analyzed 132 participants 41 participants
9.69
(7.53 to 12.5)
5.69
(4.88 to 6.63)
CYD dengue Serotype 1; 2nd year follow up Number Analyzed 128 participants 40 participants
8.31
(6.58 to 10.5)
5.91
(4.80 to 7.27)
CYD dengue Serotype 1; 3rd year follow up Number Analyzed 124 participants 40 participants
8.02
(6.30 to 10.2)
5.54
(4.79 to 6.39)
CYD dengue Serotype 1; 4th year follow up Number Analyzed 118 participants 37 participants
7.41
(5.85 to 9.38)
5.51
(4.80 to 6.34)
CYD dengue Serotype 2; Pre-Injection 1 Number Analyzed 141 participants 46 participants
7.45
(5.95 to 9.33)
5.54
(4.69 to 6.56)
CYD dengue Serotype 2; Post-Injection 3 Number Analyzed 135 participants 43 participants
48.7
(37.4 to 63.5)
6.17
(5.03 to 7.58)
CYD dengue Serotype 2; 1st year follow up Number Analyzed 131 participants 41 participants
16.6
(12.4 to 22.1)
5.58
(4.78 to 6.52)
CYD dengue Serotype 2; 2nd year follow up Number Analyzed 128 participants 40 participants
18.7
(14.1 to 24.7)
6.38
(4.92 to 8.27)
CYD dengue Serotype 2; 3rd year follow up Number Analyzed 124 participants 40 participants
13.3
(10.1 to 17.6)
5.77
(4.71 to 7.07)
CYD dengue Serotype 2; 4th year follow up Number Analyzed 116 participants 37 participants
14.0
(10.4 to 18.8)
5.80
(4.68 to 7.17)
CYD dengue Serotype 3; Pre-Injection 1 Number Analyzed 140 participants 46 participants
6.84
(5.81 to 8.06)
6.83
(4.84 to 9.65)
CYD dengue Serotype 3; Post-Injection 3 Number Analyzed 134 participants 43 participants
71.4
(56.3 to 90.7)
8.10
(5.66 to 11.6)
CYD dengue Serotype 3; 1st year follow up Number Analyzed 133 participants 40 participants
19.7
(15.1 to 25.6)
6.27
(4.55 to 8.64)
CYD dengue Serotype 3; 2nd year follow up Number Analyzed 126 participants 40 participants
20.5
(15.6 to 27.1)
7.54
(5.16 to 11.0)
CYD dengue Serotype 3; 3rd year follow up Number Analyzed 123 participants 40 participants
15.3
(11.8 to 19.9)
6.17
(4.58 to 8.31)
CYD dengue Serotype 3; 4th year follow up Number Analyzed 118 participants 37 participants
13.7
(10.7 to 17.6)
6.47
(4.49 to 9.30)
CYD dengue Serotype 4; Pre-Injection 1 Number Analyzed 140 participants 46 participants
5.83
(5.17 to 6.56)
5.08
(4.92 to 5.23)
CYD dengue Serotype 4; Post-Injection 3 Number Analyzed 135 participants 43 participants
79.2
(64.2 to 97.8)
6.45
(4.89 to 8.53)
CYD dengue Serotype 4; 1st year follow up Number Analyzed 132 participants 41 participants
30.8
(24.3 to 39)
5.17
(4.84 to 5.52)
CYD dengue Serotype 4; 2nd year follow up Number Analyzed 128 participants 40 participants
33.4
(25.6 to 43.6)
6.18
(4.99 to 7.65)
CYD dengue Serotype 4; 3rd year follow up Number Analyzed 123 participants 40 participants
23.1
(18.3 to 29.2)
5.55
(4.79 to 6.42)
CYD dengue Serotype 4; 4th year follow up Number Analyzed 118 participants 37 participants
20.8
(16.2 to 26.6)
5.43
(4.92 to 6.00)
16.Secondary Outcome
Title GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
Hide Description GMTs against each serotype with the dengue virus strain were assessed using a dengue PRNT assay.
Time Frame Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 521 174
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
CYD dengue Serotype 1; Pre-Injection 1 Number Analyzed 142 participants 49 participants
15.8
(11.7 to 21.5)
19.2
(10.9 to 33.9)
CYD dengue Serotype 1; Post-Injection 3 Number Analyzed 127 participants 43 participants
48.7
(33.6 to 70.4)
16.2
(9.77 to 27.0)
CYD dengue Serotype 1; 1st year follow up Number Analyzed 122 participants 44 participants
26.3
(17.9 to 38.6)
15.2
(8.76 to 26.3)
CYD dengue Serotype 1; 2nd year follow up Number Analyzed 117 participants 41 participants
26.3
(17.7 to 38.9)
16.3
(9.09 to 29.3)
CYD dengue Serotype 1; 3rd year follow up Number Analyzed 114 participants 39 participants
24.1
(15.9 to 36.5)
13.9
(7.89 to 24.6)
CYD dengue Serotype 1; 4th year follow up Number Analyzed 106 participants 38 participants
23.5
(15.5 to 35.5)
14.4
(8.03 to 25.6)
CYD dengue Serotype 2; Pre-Injection 1 Number Analyzed 141 participants 49 participants
16.9
(12.3 to 23.1)
21.0
(11.5 to 38.2)
CYD dengue Serotype 2; Post-Injection 3 Number Analyzed 127 participants 43 participants
66.9
(47.9 to 93.5)
15.2
(8.61 to 27.0)
CYD dengue Serotype 2; 1st year follow up Number Analyzed 122 participants 44 participants
50.4
(34.5 to 73.7)
19.3
(10.7 to 34.7)
CYD dengue Serotype 2; 2nd year follow up Number Analyzed 117 participants 41 participants
66.5
(43.7 to 101)
20.0
(10.2 to 39.0)
CYD dengue Serotype 2; 3rd year follow up Number Analyzed 114 participants 39 participants
38.4
(25.8 to 57.2)
17.0
(9.38 to 30.8)
CYD dengue Serotype 2; 4th year follow up Number Analyzed 105 participants 38 participants
32.9
(22.4 to 48.2)
15.5
(8.51 to 28.2)
CYD dengue Serotype 3; Pre-Injection 1 Number Analyzed 141 participants 48 participants
14.5
(11.2 to 18.7)
19.4
(11.4 to 33.1)
CYD dengue Serotype 3; Post-Injection 3 Number Analyzed 127 participants 43 participants
88.4
(68.6 to 114)
13.3
(8.22 to 21.7)
CYD dengue Serotype 3; 1st year follow up Number Analyzed 121 participants 44 participants
45.2
(32.1 to 63.6)
14.8
(8.96 to 24.3)
CYD dengue Serotype 3; 2nd year follow up Number Analyzed 117 participants 41 participants
64.8
(46.8 to 89.7)
19.9
(11.5 to 34.5)
CYD dengue Serotype 3; 3rd year follow up Number Analyzed 112 participants 39 participants
48.3
(33.0 to 70.8)
14.7
(8.46 to 25.7)
CYD dengue Serotype 3; 4th year follow up Number Analyzed 106 participants 37 participants
28.6
(20.2 to 40.6)
11.8
(7.18 to 19.3)
CYD dengue Serotype 4; Pre-Injection 1 Number Analyzed 140 participants 48 participants
10.1
(8.03 to 12.7)
11.7
(7.74 to 17.6)
CYD dengue Serotype 4; Post-Injection 3 Number Analyzed 126 participants 43 participants
122
(96.5 to 155)
10.0
(6.96 to 14.4)
CYD dengue Serotype 4; 1st year follow up Number Analyzed 122 participants 44 participants
70.3
(53.6 to 92.2)
9.87
(6.88 to 14.2)
CYD dengue Serotype 4; 2nd year follow up Number Analyzed 117 participants 41 participants
52.6
(39.9 to 69.3)
8.50
(6.07 to 11.9)
CYD dengue Serotype 4; 3rd year follow up Number Analyzed 114 participants 39 participants
46.4
(35.5 to 60.6)
8.39
(5.83 to 12.1)
CYD dengue Serotype 4; 4th year follow up Number Analyzed 107 participants 38 participants
32.6
(25.2 to 42.3)
7.54
(5.69 to 10.0)
17.Secondary Outcome
Title Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with antibody titers >=10 (1/dilution). Dengue participants immune at baseline was defined as those participants with titers >=10 (1/dilution) against at least one dengue serotype at baseline.
Time Frame 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 29 13
Measure Type: Number
Unit of Measure: Percentage of participants
CYD dengue Serotype 1; Post-Injection 3 Number Analyzed 27 participants 13 participants
96.3 0.0
CYD dengue Serotype 1; 1st year follow up Number Analyzed 27 participants 13 participants
74.1 7.7
CYD dengue Serotype 1; 2nd year follow up Number Analyzed 27 participants 12 participants
55.6 0.0
CYD dengue Serotype 1; 3rd year follow up Number Analyzed 27 participants 12 participants
33.3 0.0
CYD dengue Serotype 1; 4th year follow up Number Analyzed 27 participants 12 participants
22.2 0.0
CYD dengue Serotype 2; Post-Injection 3 Number Analyzed 27 participants 13 participants
100.0 15.4
CYD dengue Serotype 2; 1st year follow up Number Analyzed 27 participants 13 participants
85.2 15.4
CYD dengue Serotype 2; 2nd year follow up Number Analyzed 27 participants 12 participants
66.7 16.7
CYD dengue Serotype 2; 3rd year follow up Number Analyzed 27 participants 12 participants
48.1 16.7
CYD dengue Serotype 2; 4th year follow up Number Analyzed 27 participants 12 participants
48.1 0.0
CYD dengue Serotype 3; Post-Injection 3 Number Analyzed 27 participants 13 participants
100.0 23.1
CYD dengue Serotype 3; 1st year follow up Number Analyzed 27 participants 13 participants
88.9 7.7
CYD dengue Serotype 3; 2nd year follow up Number Analyzed 27 participants 12 participants
81.5 16.7
CYD dengue Serotype 3; 3rd year follow up Number Analyzed 27 participants 12 participants
59.3 8.3
CYD dengue Serotype 3; 4th year follow up Number Analyzed 24 participants 12 participants
50.0 0.0
CYD dengue Serotype 4; Post-Injection 3 Number Analyzed 26 participants 13 participants
100.0 23.1
CYD dengue Serotype 4; 1st year follow up Number Analyzed 27 participants 13 participants
88.9 15.4
CYD dengue Serotype 4; 2nd year follow up Number Analyzed 27 participants 12 participants
74.1 0.0
CYD dengue Serotype 4; 3rd year follow up Number Analyzed 27 participants 12 participants
70.4 16.7
CYD dengue Serotype 4; 4th year follow up Number Analyzed 27 participants 12 participants
70.4 0.0
18.Secondary Outcome
Title Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution). Dengue participants naïve at baseline was defined as those participants with titers <10 (1/dilution) against all dengue serotypes at baseline.
Time Frame 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 118 37
Measure Type: Number
Unit of Measure: Percentage of participants
CYD dengue Serotype 1; Post-Injection 3 Number Analyzed 115 participants 32 participants
89.6 12.5
CYD dengue Serotype 1; 1st year follow up Number Analyzed 113 participants 31 participants
33.6 6.5
CYD dengue Serotype 1; 2nd year follow up Number Analyzed 112 participants 31 participants
20.5 0.0
CYD dengue Serotype 1; 3rd year follow up Number Analyzed 105 participants 31 participants
12.4 0.0
CYD dengue Serotype 1; 4th year follow up Number Analyzed 108 participants 30 participants
6.5 0.0
CYD dengue Serotype 2; Post-Injection 3 Number Analyzed 115 participants 32 participants
93.0 12.5
CYD dengue Serotype 2; 1st year follow up Number Analyzed 113 participants 32 participants
54.0 6.3
CYD dengue Serotype 2; 2nd year follow up Number Analyzed 112 participants 31 participants
49.1 9.7
CYD dengue Serotype 2; 3rd year follow up Number Analyzed 106 participants 31 participants
31.1 3.2
CYD dengue Serotype 2; 4th year follow up Number Analyzed 102 participants 30 participants
34.3 3.3
CYD dengue Serotype 3; Post-Injection 3 Number Analyzed 115 participants 31 participants
97.4 9.7
CYD dengue Serotype 3; 1st year follow up Number Analyzed 113 participants 31 participants
60.2 9.7
CYD dengue Serotype 3; 2nd year follow up Number Analyzed 105 participants 29 participants
72.4 34.5
CYD dengue Serotype 3; 3rd year follow up Number Analyzed 106 participants 31 participants
47.2 3.2
CYD dengue Serotype 3; 4th year follow up Number Analyzed 105 participants 30 participants
34.3 3.3
CYD dengue Serotype 4; Post-Injection 3 Number Analyzed 115 participants 31 participants
96.5 19.4
CYD dengue Serotype 4; 1st year follow Number Analyzed 113 participants 30 participants
71.7 0.0
CYD dengue Serotype 4; 2nd year follow up Number Analyzed 112 participants 31 participants
73.2 6.5
CYD dengue Serotype 4; 3rd year follow up Number Analyzed 104 participants 31 participants
58.7 3.2
CYD dengue Serotype 4; 4th year follow up Number Analyzed 108 participants 30 participants
44.4 0.0
19.Secondary Outcome
Title Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution). Dengue participants immune at baseline was defined as those participants with titers >=10 (1/dilution) against at least one dengue serotype at baseline.
Time Frame 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 19 7
Measure Type: Number
Unit of Measure: Percentage of participants
CYD dengue Serotype 1; Post-Injection 3 Number Analyzed 18 participants 6 participants
94.4 33.3
CYD dengue Serotype 1; 1st year follow up Number Analyzed 17 participants 5 participants
58.8 20.0
CYD dengue Serotype 1; 2nd year follow up Number Analyzed 15 participants 6 participants
46.7 16.7
CYD dengue Serotype 1; 3rd year follow up Number Analyzed 16 participants 6 participants
43.8 16.7
CYD dengue Serotype 1; 4th year follow up Number Analyzed 14 participants 5 participants
42.9 20.0
CYD dengue Serotype 2; Post-Injection 3 Number Analyzed 18 participants 6 participants
94.4 16.7
CYD dengue Serotype 2; 1st year follow up Number Analyzed 17 participants 5 participants
82.4 20.0
CYD dengue Serotype 2; 2nd year follow up Number Analyzed 15 participants 6 participants
73.3 33.3
CYD dengue Serotype 2; 3rd year follow up Number Analyzed 16 participants 6 participants
68.8 16.7
CYD dengue Serotype 2; 4th year follow up Number Analyzed 14 participants 5 participants
71.4 20.0
CYD dengue Serotype 3; Post-Injection 3 Number Analyzed 18 participants 6 participants
100.0 50.0
CYD dengue Serotype 3; 1st year follow up Number Analyzed 17 participants 5 participants
76.5 20.0
CYD dengue Serotype 3; 2nd year follow up Number Analyzed 15 participants 6 participants
80.0 50.0
CYD dengue Serotype 3; 3rd year follow up Number Analyzed 16 participants 6 participants
68.8 16.7
CYD dengue Serotype 3; 4th year follow up Number Analyzed 14 participants 5 participants
71.4 20.0
CYD dengue Serotype 4; Post-Injection 3 Number Analyzed 18 participants 6 participants
100.0 33.3
CYD dengue Serotype 4; 1st year follow up Number Analyzed 17 participants 5 participants
100.0 20.0
CYD dengue Serotype 4; 2nd year follow up Number Analyzed 15 participants 6 participants
100.0 16.7
CYD dengue Serotype 4; 3rd year follow up Number Analyzed 16 participants 6 participants
93.8 16.7
CYD dengue Serotype 4; 4th year follow up Number Analyzed 14 participants 5 participants
100.0 20.0
20.Secondary Outcome
Title Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against each serotype with the dengue virus strain were assessed using a PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution). Dengue participants naïve at baseline was defined as those participants with titers <10 (1/dilution) against all dengue serotypes at baseline.
Time Frame 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 121 39
Measure Type: Number
Unit of Measure: Percentage of participants
CYD dengue Serotype 1; Post-Injection 3 Number Analyzed 116 participants 37 participants
62.9 8.1
CYD dengue Serotype 1; 1st year follow up Number Analyzed 115 participants 36 participants
20.9 5.6
CYD dengue Serotype 1; 2nd year follow up Number Analyzed 112 participants 34 participants
16.1 5.9
CYD dengue Serotype 1; 3rd year follow up Number Analyzed 108 participants 34 participants
12.0 2.9
CYD dengue Serotype 1; 4th year follow up Number Analyzed 104 participants 32 participants
7.7 3.1
CYD dengue Serotype 2; Post-Injection 3 Number Analyzed 116 participants 37 participants
81.9 8.1
CYD dengue Serotype 2; 1st year follow up Number Analyzed 114 participants 36 participants
38.6 2.8
CYD dengue Serotype 2; 2nd year follow up Number Analyzed 112 participants 34 participants
49.1 5.9
CYD dengue Serotype 2; 3rd year follow up Number Analyzed 108 participants 34 participants
30.6 2.9
CYD dengue Serotype 2; 4th year follow up Number Analyzed 102 participants 32 participants
31.4 3.1
CYD dengue Serotype 3; Post-Injection 3 Number Analyzed 115 participants 37 participants
87.0 16.2
CYD dengue Serotype 3; 1st year follow up Number Analyzed 116 participants 35 participants
59.5 2.9
CYD dengue Serotype 3; 2nd year follow up Number Analyzed 110 participants 34 participants
53.6 5.9
CYD dengue Serotype 3; 3rd year follow up Number Analyzed 107 participants 34 participants
45.8 2.9
CYD dengue Serotype 3; 4th year follow up Number Analyzed 104 participants 32 participants
44.2 3.1
CYD dengue Serotype 4; Post-Injection 3 Number Analyzed 116 participants 37 participants
89.7 5.4
CYD dengue Serotype 4; 1st year follow up Number Analyzed 115 participants 36 participants
69.6 0.0
CYD dengue Serotype 4; 2nd year follow up Number Analyzed 112 participants 34 participants
67.0 8.8
CYD dengue Serotype 4; 3rd year follow up Number Analyzed 107 participants 34 participants
62.6 2.9
CYD dengue Serotype 4; 4th year follow up Number Analyzed 104 participants 32 participants
55.8 6.3
21.Secondary Outcome
Title Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution). Dengue participants immune at baseline was defined as those participants with titers >=10 (1/dilution) against at least one dengue serotype at baseline.
Time Frame 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 66 27
Measure Type: Number
Unit of Measure: Percentage of participants
CYD dengue Serotype 1; Post-Injection 3 Number Analyzed 56 participants 20 participants
89.3 70.0
CYD dengue Serotype 1; 1st year follow up Number Analyzed 54 participants 21 participants
77.8 57.1
CYD dengue Serotype 1; 2nd year follow up Number Analyzed 51 participants 20 participants
86.3 65.0
CYD dengue Serotype 1; 3rd year follow up Number Analyzed 52 participants 19 participants
80.8 63.2
CYD dengue Serotype 1; 4th year follow up Number Analyzed 46 participants 18 participants
84.8 66.7
CYD dengue Serotype 2; Post-Injection 3 Number Analyzed 56 participants 20 participants
91.1 65.0
CYD dengue Serotype 2; 1st year follow up Number Analyzed 54 participants 21 participants
88.9 71.4
CYD dengue Serotype 2; 2nd year follow up Number Analyzed 51 participants 20 participants
92.2 70.0
CYD dengue Serotype 2; 3rd year follow up Number Analyzed 52 participants 19 participants
88.5 68.4
CYD dengue Serotype 2; 4th year follow up Number Analyzed 47 participants 18 participants
91.5 66.7
CYD dengue Serotype 3; Post-Injection 3 Number Analyzed 56 participants 20 participants
98.2 60.0
CYD dengue Serotype 3; 1st year follow up Number Analyzed 54 participants 21 participants
90.7 66.7
CYD dengue Serotype 3; 2nd year follow up Number Analyzed 51 participants 20 participants
98.0 70.0
CYD dengue Serotype 3; 3rd year follow up Number Analyzed 52 participants 19 participants
94.2 73.7
CYD dengue Serotype 3; 4th year follow up Number Analyzed 47 participants 18 participants
91.5 61.1
CYD dengue Serotype 4; Post-Injection 3 Number Analyzed 55 participants 20 participants
100.0 65.0
CYD dengue Serotype 4; 1st year follow up Number Analyzed 54 participants 21 participants
98.1 47.6
CYD dengue Serotype 4; 2nd year follow up Number Analyzed 51 participants 20 participants
96.1 45.0
CYD dengue Serotype 4; 3rd year follow up Number Analyzed 52 participants 19 participants
100.0 42.1
CYD dengue Serotype 4; 4th year follow up Number Analyzed 47 participants 18 participants
97.9 44.4
22.Secondary Outcome
Title Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers >=10 (1/dilution). Dengue participants naïve at baseline was defined as those participants with titers <10 (1/dilution) against all dengue serotypes at baseline.
Time Frame 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
Overall Number of Participants Analyzed 74 22
Measure Type: Number
Unit of Measure: Percentage of participants
CYD dengue Serotype 1; Post-Injection 3 Number Analyzed 64 participants 21 participants
59.4 14.3
CYD dengue Serotype 1; 1st year follow up Number Analyzed 61 participants 21 participants
21.3 9.5
CYD dengue Serotype 1; 2nd year follow up Number Analyzed 59 participants 19 participants
10.2 5.3
CYD dengue Serotype 1; 3rd year follow up Number Analyzed 56 participants 18 participants
7.1 0
CYD dengue Serotype 1; 4th year follow up Number Analyzed 54 participants 18 participants
5.6 0
CYD dengue Serotype 2; Post-Injection 3 Number Analyzed 64 participants 21 participants
73.4 0
CYD dengue Serotype 2; 1st year follow up Number Analyzed 61 participants 21 participants
49.2 14.3
CYD dengue Serotype 2; 2nd year follow up Number Analyzed 59 participants 19 participants
50.8 0
CYD dengue Serotype 2; 3rd year follow up Number Analyzed 56 participants 18 participants
28.6 5.6
CYD dengue Serotype 2; 4th year follow up Number Analyzed 53 participants 18 participants
26.4 0
CYD dengue Serotype 3; Post-Injection 3 Number Analyzed 64 participants 21 participants
87.5 14.3
CYD dengue Serotype 3; 1st year follow up Number Analyzed 60 participants 21 participants
48.3 14.3
CYD dengue Serotype 3; 2nd year follow up Number Analyzed 59 participants 19 participants
61.0 21.1
CYD dengue Serotype 3; 3rd year follow up Number Analyzed 54 participants 18 participants
46.3 0
CYD dengue Serotype 3; 4th year follow up Number Analyzed 53 participants 17 participants
28.3 0
CYD dengue Serotype 4; Post-Injection 3 Number Analyzed 64 participants 21 participants
87.5 4.8
CYD dengue Serotype 4; 1st year follow up Number Analyzed 61 participants 21 participants
78.7 14.3
CYD dengue Serotype 4; 2nd year follow up Number Analyzed 59 participants 19 participants
71.2 5.3
CYD dengue Serotype 4; 3rd year follow up Number Analyzed 56 participants 18 participants
66.1 0
CYD dengue Serotype 4; 4th year follow up Number Analyzed 54 participants 18 participants
63.0 0
Time Frame Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Adverse Event Reporting Description Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
 
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively. All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
All-Cause Mortality
CYD Dengue Vaccine Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   3/898 (0.33%)      0/300 (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   43/898 (4.79%)      13/300 (4.33%)    
Cardiac disorders     
Acute coronary syndrome * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Endocrine disorders     
Hyperthyroidism * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Thyroid disorder * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain * 1  1/898 (0.11%)  1 1/300 (0.33%)  1
Colitis * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Diarrhoea * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Gingivitis * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
General disorders     
Adverse drug reaction * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Chest pain * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Infections and infestations     
Appendicitis * 1  2/898 (0.22%)  2 0/300 (0.00%)  0
Bronchitis * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Conjunctivitis viral * 1  2/898 (0.22%)  2 0/300 (0.00%)  0
Corneal infection * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Dengue fever * 1  3/898 (0.33%)  3 0/300 (0.00%)  0
Gastroenteritis * 1  2/898 (0.22%)  3 1/300 (0.33%)  1
Gastroenteritis viral * 1  1/898 (0.11%)  1 2/300 (0.67%)  2
Groin abscess * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Hand-foot-and-mouth disease * 1  2/898 (0.22%)  2 0/300 (0.00%)  0
Herpangina * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Lymph node tuberculosis * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Meningitis viral * 1  0/898 (0.00%)  0 1/300 (0.33%)  1
Pharyngitis * 1  1/898 (0.11%)  1 1/300 (0.33%)  1
Pharyngitis bacterial * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Subcutaneous abscess * 1  1/898 (0.11%)  1 1/300 (0.33%)  1
Upper respiratory tract infection * 1  2/898 (0.22%)  2 0/300 (0.00%)  0
Viral infection * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Injury, poisoning and procedural complications     
Foot fracture * 1  0/898 (0.00%)  0 1/300 (0.33%)  1
Hand fracture * 1  0/898 (0.00%)  0 1/300 (0.33%)  1
Intentional overdose * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Traumatic haematoma * 1  0/898 (0.00%)  0 1/300 (0.33%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Back pain * 1  0/898 (0.00%)  0 1/300 (0.33%)  2
Intervertebral disc protrusion * 1  0/898 (0.00%)  0 1/300 (0.33%)  1
Musculoskeletal pain * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute leukaemia * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Acute lymphocytic leukaemia * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Ovarian cancer metastatic * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Ovarian germ cell teratoma benign * 1  0/898 (0.00%)  0 1/300 (0.33%)  1
Papillary thyroid cancer * 1  0/898 (0.00%)  0 1/300 (0.33%)  1
Nervous system disorders     
Migraine * 1  2/898 (0.22%)  2 0/300 (0.00%)  0
Radial nerve palsy * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Syncope vasovagal * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Tension headache * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Ruptured ectopic pregnancy * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Psychiatric disorders     
Depression * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Reproductive system and breast disorders     
Ovarian cyst * 1  0/898 (0.00%)  0 1/300 (0.33%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  2/898 (0.22%)  2 1/300 (0.33%)  2
Bronchial hyperreactivity * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Rhinitis allergic * 1  1/898 (0.11%)  1 0/300 (0.00%)  0
Surgical and medical procedures     
Osteotomy * 1  1/898 (0.11%)  1 0/300 (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 Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   481/898 (53.56%)      198/300 (66.00%)    
General disorders     
Injection site Pain; Post-Any Injection  1  481/892 (53.92%)  481 198/297 (66.67%)  198
Injection site Erythema; Post-Any Injection  1  64/891 (7.18%)  64 45/297 (15.15%)  45
Injection site Swelling; Post-Any Injection  1  37/892 (4.15%)  37 25/297 (8.42%)  25
Fever; Post-Any Injection  1  101/892 (11.32%)  101 22/297 (7.41%)  22
Malaise; Post-Any Injection  1  372/891 (41.75%)  372 105/297 (35.35%)  105
Asthenia; Post-Any Injection  1  183/891 (20.54%)  183 52/297 (17.51%)  52
Infections and infestations     
Upper respiratory tract infection * 1  72/898 (8.02%)  77 27/300 (9.00%)  30
Musculoskeletal and connective tissue disorders     
Myalgia; Post-Any Injection  1  394/891 (44.22%)  394 130/297 (43.77%)  130
Nervous system disorders     
Headache; Post-Any Injection  1  402/891 (45.12%)  402 114/297 (38.38%)  114
Respiratory, thoracic and mediastinal disorders     
Cough * 1  42/898 (4.68%)  48 15/300 (5.00%)  17
Rhinorrhoea * 1  42/898 (4.68%)  47 15/300 (5.00%)  15
1
Term from vocabulary, MedDRA (11.0)
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-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
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00880893     History of Changes
Other Study ID Numbers: CYD28
2014-001713-26 ( EudraCT Number )
First Submitted: April 13, 2009
First Posted: April 14, 2009
Results First Submitted: April 16, 2019
Results First Posted: July 29, 2019
Last Update Posted: July 29, 2019