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Trial record 1 of 1 for:    CYD57
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Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study

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ClinicalTrials.gov Identifier: NCT01983553
Recruitment Status : Completed
First Posted : November 14, 2013
Results First Posted : July 29, 2019
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Dengue
Dengue Fever
Dengue Hemorrhagic Fever
Enrollment 3203
Recruitment Details Study participants were enrolled in the original study CYD23 (NCT00842530) from 10 September 2013 to 29 November 2013 at 1 clinic center in Thailand.
Pre-assignment Details Of the 3997 participants who were treated in the original study CYD23, a total of 3203 participants were included in this CYD57 study to continue the 4-year safety follow-up.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23. Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Period Title: Overall Study
Started 2131 1072
Completed 2131 1072
Not Completed 0 0
Arm/Group Title CYD Dengue Vaccine Group Control Group Total
Hide Arm/Group Description Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23. Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23. Total of all reporting groups
Overall Number of Baseline Participants 2131 1072 3203
Hide Baseline Analysis Population Description
Analysis was performed on Follow-up Analysis Set (FupAS) which included all participants who were included in the study CYD57.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2131 participants 1072 participants 3203 participants
<=18 years
2131
 100.0%
1072
 100.0%
3203
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2131 participants 1072 participants 3203 participants
8.11  (2.02) 8.15  (2.06) 8.13  (2.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2131 participants 1072 participants 3203 participants
Female
1118
  52.5%
579
  54.0%
1697
  53.0%
Male
1013
  47.5%
493
  46.0%
1506
  47.0%
1.Primary Outcome
Title Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23)
Hide Description Event rate per 100 participant-years for hospitalized VCD cases, due to any and each serotype (1, 2, 3 and 4) following vaccination with either CYD Dengue vaccine or Placebo in the previous study (CYD23) were reported.
Time Frame Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FupAS.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Overall Number of Participants Analyzed 2131 1072
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Events per 100 participant-years
Any of the 4 Serotypes
1.0
(0.8 to 1.2)
1.1
(0.8 to 1.4)
Serotype 1
0.2
(0.2 to 0.4)
0.3
(0.1 to 0.5)
Serotype 2
0.3
(0.2 to 0.5)
0.3
(0.1 to 0.5)
Serotype 3
0.2
(0.2 to 0.4)
0.2
(0.1 to 0.4)
Serotype 4
0.2
(0.1 to 0.3)
0.3
(0.1 to 0.5)
Unserotyped
0.0
(0.0 to 0.0)
0.1
(0.0 to 0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative risk; Any of the 4 Serotypes
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes between the CYD Dengue vaccine group and the Control group.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.930
Confidence Interval (2-Sided) 95%
0.64 to 1.36
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative risk; Serotype 1
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 between the CYD Dengue vaccine group and the Control group.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.960
Confidence Interval (2-Sided) 95%
0.44 to 2.21
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative risk; Serotype 2
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 between the CYD Dengue vaccine group and the Control group.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 1.326
Confidence Interval (2-Sided) 95%
0.64 to 2.94
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative risk; Serotype 3
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 3 between the CYD Dengue vaccine group and the Control group.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 1.056
Confidence Interval (2-Sided) 95%
0.48 to 2.51
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative risk; Serotype 4
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 between the CYD Dengue vaccine group and the Control group.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.629
Confidence Interval (2-Sided) 95%
0.27 to 1.47
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative risk; Unserotyped
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped between the CYD Dengue vaccine group and the Control group.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.000
Confidence Interval (2-Sided) 95%
0.00 to 1.22
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
2.Primary Outcome
Title Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23)
Hide Description Cases were defined as the number of participants with at least one hospitalized VCD episode.
Time Frame Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FupAS.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Overall Number of Participants Analyzed 2131 1072
Measure Type: Number
Unit of Measure: Cases
Cases: Any of the 4 Serotypes 85 46
Cases: Serotype 1 21 11
Cases: Serotype 2 29 11
Cases: Serotype 3 21 10
Cases: Serotype 4 15 12
Cases: Unserotyped 0 3
3.Primary Outcome
Title Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23)
Hide Description Episodes were defined as the number of hospitalized VCD episodes.
Time Frame Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FupAS.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Overall Number of Participants Analyzed 2131 1072
Measure Type: Number
Unit of Measure: Episodes
Episodes: Any of the 4 Serotypes 85 46
Episodes: Serotype 1 21 11
Episodes: Serotype 2 29 11
Episodes: Serotype 3 21 10
Episodes: Serotype 4 15 12
Episodes: Unserotyped 0 3
4.Primary Outcome
Title Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Hide Description Event rate per 100 participant-years for hospitalized VCD cases, due to any and each serotype (1, 2, 3 and 4) following vaccination with either CYD Dengue vaccine or Placebo in the previous study (CYD23) were reported. Endpoint values <0.1 were rounded to 0.1.
Time Frame Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FupAS. Here, "number analyzed" signifies participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Overall Number of Participants Analyzed 2131 1072
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Events per 100 participant-years
4 to 5 Years: Any of the 4 Serotypes Number Analyzed 393 participants 192 participants
1.7
(1.1 to 2.4)
1.2
(0.5 to 2.2)
6 to 11 Years: Any of the 4 Serotypes Number Analyzed 1738 participants 880 participants
0.8
(0.6 to 1.1)
1.1
(0.7 to 1.4)
4 to 5 Years: Serotype 1 Number Analyzed 393 participants 192 participants
0.6
(0.3 to 1.2)
0.1
(0.0 to 0.7)
6 to 11 Years: Serotype 1 Number Analyzed 1738 participants 880 participants
0.2
(0.1 to 0.3)
0.3
(0.1 to 0.5)
4 to 5 Years: Serotype 2 Number Analyzed 393 participants 192 participants
0.4
(0.1 to 0.8)
0.1
(0.0 to 0.7)
6 to 11 Years: Serotype 2 Number Analyzed 1738 participants 880 participants
0.3
(0.2 to 0.5)
0.3
(0.1 to 0.5)
4 to 5 Years: Serotype 3 Number Analyzed 393 participants 192 participants
0.3
(0.1 to 0.7)
0.3
(0.0 to 0.9)
6 to 11 Years: Serotype 3 Number Analyzed 1738 participants 880 participants
0.2
(0.1 to 0.4)
0.2
(0.1 to 0.4)
4 to 5 Years: Serotype 4 Number Analyzed 393 participants 192 participants
0.4
(0.1 to 0.8)
0.4
(0.1 to 1.1)
6 to 11 Years: Serotype 4 Number Analyzed 1738 participants 880 participants
0.1
(0.1 to 0.2)
0.3
(0.1 to 0.5)
4 to 5 Years: Unserotyped Number Analyzed 393 participants 192 participants
0.0
(0.0 to 0.2)
0.3
(0.0 to 0.9)
6 to 11 Years: Unserotyped Number Analyzed 1738 participants 880 participants
0.0
(0.0 to 0.1)
0.1
(0.0 to 0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; 4 to 5 years; Any Serotype
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 1.411
Confidence Interval (2-Sided) 95%
0.64 to 3.42
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; 6 to 11 years; Any Serotype
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.807
Confidence Interval (2-Sided) 95%
0.53 to 1.25
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; 4 to 5 years; Serotype 1
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 4.885
Confidence Interval (2-Sided) 95%
0.70 to 212.02
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; 6 to 11 years; Serotype 1
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.557
Confidence Interval (2-Sided) 95%
0.21 to 1.46
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; 4 to 5 years; Serotype 2
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 2.931
Confidence Interval (2-Sided) 95%
0.36 to 134.83
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; 6 to 11 years; Serotype 2
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 1.165
Confidence Interval (2-Sided) 95%
0.53 to 2.74
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; 4 to 5 years; Serotype 3
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants at Year 1 for Serotype 3 (4 to 5 year) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 1.221
Confidence Interval (2-Sided) 95%
0.20 to 12.83
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; 6 to 11 years; Serotype 3
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 3 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 1.013
Confidence Interval (2-Sided) 95%
0.41 to 2.73
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; 4 to 5 years; Serotype 4
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.977
Confidence Interval (2-Sided) 95%
0.21 to 6.04
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; 6 to 11 years; Serotype 4
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.506
Confidence Interval (2-Sided) 95%
0.18 to 1.44
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; 4 to 5 years; Unserotyped
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.000
Confidence Interval (2-Sided) 95%
0.00 to 2.60
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; 6 to 11 years; Unserotyped
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.000
Confidence Interval (2-Sided) 95%
0.00 to 19.75
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
5.Primary Outcome
Title Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Hide Description Cases were defined as the number of participants with at least one hospitalized VCD episode.
Time Frame Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FupAS. Here, “number analyzed” signifies participants with evaluable data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Overall Number of Participants Analyzed 2131 1072
Measure Type: Number
Unit of Measure: Cases
4 to 5 years cases: Any of the 4 serotype Number Analyzed 393 participants 192 participants
26 9
6 to 11 years cases: Any of the 4 Serotypes Number Analyzed 1738 participants 880 participants
59 37
4 to 5 years cases: Serotype 1 Number Analyzed 393 participants 192 participants
10 1
6 to 11 years cases: Serotype 1 Number Analyzed 1738 participants 880 participants
11 10
4 to 5 years cases: Serotype 2 Number Analyzed 393 participants 192 participants
6 1
6 to 11 years cases: Serotype 2 Number Analyzed 1738 participants 880 participants
23 10
4 to 5 years cases: Serotype 3 Number Analyzed 393 participants 192 participants
5 2
6 to 11 years cases: Serotype 3 Number Analyzed 1738 participants 880 participants
16 8
4 to 5 years cases: Serotype 4 Number Analyzed 393 participants 192 participants
6 3
6 to 11 years cases: Serotype 4 Number Analyzed 1738 participants 880 participants
9 9
4 to 5 years cases: Unserotyped Number Analyzed 393 participants 192 participants
0 2
6 to 11 years cases: Unserotyped Number Analyzed 1738 participants 880 participants
0 1
6.Primary Outcome
Title Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Hide Description Episodes were defined as the number of hospitalized VCD episodes.
Time Frame Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FupAS. Here, “number analyzed” signifies participants with evaluable data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Overall Number of Participants Analyzed 2131 1072
Measure Type: Number
Unit of Measure: Episodes
4 to 5 years episodes: Any of 4 serotype Number Analyzed 393 participants 192 participants
26 9
6 to11 years episodes: Any of 4 Serotypes Number Analyzed 1738 participants 880 participants
59 37
4 to 5 years episodes: Serotype 1 Number Analyzed 393 participants 192 participants
10 1
6 to 11 years episodes: Serotype 1 Number Analyzed 1738 participants 880 participants
11 10
4 to 5 years episodes: Serotype 2 Number Analyzed 393 participants 192 participants
6 1
6 to 11 years episodes: Serotype 2 Number Analyzed 1738 participants 880 participants
23 10
4 to 5 years episodes: Serotype 3 Number Analyzed 393 participants 192 participants
5 2
6 to 11 years episodes: Serotype 3 Number Analyzed 1738 participants 880 participants
16 8
4 to 5 years episodes: Serotype 4 Number Analyzed 393 participants 192 participants
6 3
6 to 11 years episodes: Serotype 4 Number Analyzed 1738 participants 880 participants
9 9
4 to 5 years episodes: Unserotyped Number Analyzed 393 participants 192 participants
0 2
6 to 11 years episodes: Unserotyped Number Analyzed 1738 participants 880 participants
0 1
7.Primary Outcome
Title Event Rate Per 100 Participant-years for Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Hide Description Event rate per 100 participant-years for Clinically Severe hospitalized VCD cases, due to any and each serotype (1, 2, 3 and 4) following vaccination with either CYD Dengue vaccine or Placebo in the previous study (CYD23) were reported. Endpoint values <0.1 were rounded to 0.1.
Time Frame Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FupAS.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Overall Number of Participants Analyzed 2131 1072
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Events per 100 participant-years
Any of the 4 Serotypes
0.1
(0.0 to 0.2)
0.1
(0.0 to 0.2)
Serotype 1
0.1
(0.0 to 0.2)
0.0
(0.0 to 0.1)
Serotype 2
0.1
(0.0 to 0.1)
0.1
(0.0 to 0.1)
Serotype 3
0.1
(0.0 to 0.1)
0.0
(0.0 to 0.1)
Serotype 4
0.1
(0.0 to 0.1)
0.1
(0.0 to 0.2)
Unserotyped
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.1)
8.Primary Outcome
Title Number of Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Hide Description Cases were defined as the number of participants with at least one hospitalized VCD episode.
Time Frame Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FupAS.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Overall Number of Participants Analyzed 2131 1072
Measure Type: Number
Unit of Measure: Cases
Cases: Any of the 4 Serotypes 8 3
Cases: Serotype 1 6 0
Cases: Serotype 2 1 1
Cases: Serotype 3 1 0
Cases: Serotype 4 1 2
Cases: Unserotyped 0 0
9.Primary Outcome
Title Number of Episodes of Clinically Severe Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Hide Description Episodes were defined as the number of hospitalized VCD episodes.
Time Frame Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FupAS.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Overall Number of Participants Analyzed 2131 1072
Measure Type: Number
Unit of Measure: Episodes
Episodes: Any of the 4 Serotypes 8 3
Episodes: Serotype 1 6 0
Episodes: Serotype 2 1 1
Episodes: Serotype 3 1 0
Episodes: Serotype 4 1 2
Episodes: Unserotyped 0 0
10.Primary Outcome
Title Number of Cases of Non-Serotype Specific Dengue Viremia Among Hospitalized VCD Cases Following Vaccination With CYD Dengue Vaccine or Placebo in Previous Study (CYD23)
Hide Description Cases were defined as the number of participants with at least one non-serotype specific dengue viremia among hospitalized VCD cases.
Time Frame During Year 1 to Year 4 post 3rd vaccination at Month 12 in CYD23 at each of the following time points: Anytime, 0-3 days, 4-7 days, 0-7 days, After 7 days during the sera sample collection time interval of 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FupAS. Here, 'number analyzed' = number of hospitalized VCD episodes in the specified time period.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Overall Number of Participants Analyzed 2131 1072
Measure Type: Number
Unit of Measure: Participants
Cases - Anytime 78 42
Cases - 0-3 days 25 12
Cases - 4-7 days 53 27
Cases - 0-7 days 78 39
Cases - After 7 days NA [1]  3
[1]
No hospitalized VCD case occurred in this specified time period.
11.Primary Outcome
Title Non-Serotype Specific Dengue Viremia Among Hospitalized VCD Cases Following Vaccination With CYD Dengue Vaccine or Placebo in Previous Study (CYD23)
Hide Description Quantified viremia was defined as greater than or equal to (>=) lower limit of quantitation (log10 plaque forming unit [pfu]/mL).
Time Frame Year 1 to Year 4 post-vaccination after 3rd vaccination at Month 12 in CYD23 at each of the following time points: Anytime, 0-3 days, 4-7 days, 0-7 days, After 7 days during the sample collection time interval of 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FupAS. Here, 'number analyzed' = number of hospitalized VCD episodes in the specified time period.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Overall Number of Participants Analyzed 2131 1072
Mean (Standard Deviation)
Unit of Measure: log10 pfu/mL
Mean Viremia - Anytime 3.64  (1.17) 3.38  (1.21)
Mean Viremia - 0-3 days 4.35  (1.11) 3.83  (1.53)
Mean Viremia - 4-7 days 3.31  (1.06) 3.12  (0.957)
Mean Viremia - 0-7 days 3.64  (1.17) 3.34  (1.19)
Mean Viremia - After 7 days NA [1]   (NA) 3.88  (1.63)
[1]
No hospitalized VCD case occurred in this specified time period.
12.Primary Outcome
Title Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Hide Description Event rate per 100 participant-years for hospitalized VCD cases, due to any and each serotype (1, 2, 3 and 4) following vaccination with either CYD Dengue vaccine or Placebo in the previous study (CYD23) were reported. Endpoint values <0.1 were rounded to 0.1. The WHO criteria were fever, any haemorrhagic manifestations, thrombocytopenia, plasma leakage or pleural effusion and/or ascites and/or hypoalbuminemia. Dengue haemorrhagic fever was graded as Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test. Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhages. Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness. Grade IV: Profound shock with undetectable blood pressure and pulse.
Time Frame Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FupAS.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Overall Number of Participants Analyzed 2131 1072
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Events per 100 participant-years
Any of the 4 Serotypes: Any Grade
0.1
(0.0 to 0.2)
0.1
(0.0 to 0.2)
Any of the 4 Serotypes: Grade I
0.1
(0.0 to 0.1)
0.1
(0.0 to 0.2)
Any of the 4 Serotypes: Grade II
0.1
(0.0 to 0.1)
0.1
(0.0 to 0.1)
Any of the 4 Serotypes: Grade III
0.1
(0.0 to 0.1)
0.0
(0.0 to 0.1)
Any of the 4 Serotypes: Grade IV
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.1)
Serotype 1: Any Grade
0.1
(0.0 to 0.1)
0.0
(0.0 to 0.1)
Serotype 1: Grade I
0.1
(0.0 to 0.1)
0.0
(0.0 to 0.1)
Serotype 1: Grade II
0.1
(0.0 to 0.1)
0.0
(0.0 to 0.1)
Serotype 1: Grade III
0.1
(0.0 to 0.1)
0.0
(0.0 to 0.1)
Serotype 1: Grade IV
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.1)
Serotype 2: Any Grade
0.1
(0.0 to 0.1)
0.1
(0.0 to 0.1)
Serotype 2: Grade I
0.1
(0.0 to 0.1)
0.1
(0.0 to 0.1)
Serotype 2: Grade II
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.1)
Serotype 2: Grade III
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.1)
Serotype 2: Grade IV
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.1)
Serotype 3: Any Grade
0.1
(0.0 to 0.1)
0.0
(0.0 to 0.1)
Serotype 3: Grade I
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.1)
Serotype 3: Grade II
0.1
(0.0 to 0.1)
0.0
(0.0 to 0.1)
Serotype 3 Grade III
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.1)
Serotype 3: Grade IV
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.1)
Serotype 4: Any Grade
0.1
(0.0 to 0.1)
0.1
(0.0 to 0.2)
Serotype 4: Grade I
0.0
(0.0 to 0.0)
0.1
(0.0 to 0.1)
Serotype 4: Grade II
0.1
(0.0 to 0.1)
0.1
(0.0 to 0.1)
Serotype 4: Grade III
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.1)
Serotype 4: Grade IV
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.1)
Unserotyped: Any Grade
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.1)
Unserotyped: Grade I
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.1)
Unserotyped: Grade II
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.1)
Unserotyped: Grade III
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.1)
Unserotyped: Grade IV
0.0
(0.0 to 0.0)
0.0
(0.0 to 0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; Any serotype; Any grade
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes; Any grade between the CYD Dengue vaccine group and the Control group.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 1.174
Confidence Interval (2-Sided) 95%
0.27 to 7.03
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; Any serotype; Grade I
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes; Grade I between the CYD Dengue vaccine group and the Control group.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.252
Confidence Interval (2-Sided) 95%
0.00 to 4.83
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; Any serotype; Grade II
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes Grade II between the CYD Dengue vaccine group and the Control group.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 2.012
Confidence Interval (2-Sided) 95%
0.20 to 99.10
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; Serotype 2; Any grade
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 Any grade between the CYD Dengue vaccine group and the Control group.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.503
Confidence Interval (2-Sided) 95%
0.01 to 39.49
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; Serotype 2; Grade I
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 Grade I between the CYD Dengue vaccine group and the Control group.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.503
Confidence Interval (2-Sided) 95%
0.01 to 39.49
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; Serotype 4; Any grade
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Any grade between the CYD Dengue vaccine group and the Control group.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.252
Confidence Interval (2-Sided) 95%
0.00 to 4.83
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; Serotype 4; Grade I
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Grade I between the CYD Dengue vaccine group and the Control group.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.000
Confidence Interval (2-Sided) 95%
0.00 to 19.62
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Group, Control Group
Comments Relative Risk; Serotype 4; Grade II
Type of Statistical Test Other
Comments Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Grade II between the CYD Dengue vaccine group and the Control group.
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 0.503
Confidence Interval (2-Sided) 95%
0.01 to 39.49
Estimation Comments The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.
13.Primary Outcome
Title Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Hide Description Cases were defined as the number of participants with at least one hospitalized VCD episode meeting WHO criteria. The WHO criteria was fever, any haemorrhagic manifestations, thrombocytopenia, plasma leakage or pleural effusion and/or ascites and/or hypoalbuminemia. Dengue hemorrhagic fever was graded as - Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation was a positive tourniquet test. Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhages. Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness. Grade IV: Profound shock with undetectable blood pressure and pulse.
Time Frame Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FupAS.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Overall Number of Participants Analyzed 2131 1072
Measure Type: Number
Unit of Measure: Cases
Cases: Any of the 4 Serotypes: Any Grade 7 3
Cases: Any of the 4 Serotypes: Grade I 1 2
Cases: Any of the 4 Serotypes: Grade II 4 1
Cases: Any of the 4 Serotypes: Grade III 2 0
Cases: Any of the 4 Serotypes: Grade IV 0 0
Cases: Serotype 1: Any Grade 5 0
Cases: Serotype 1: Grade I 1 0
Cases: Serotype 1: Grade II 2 0
Cases: Serotype 1: Grade III 2 0
Cases: Serotype 1: Grade IV 0 0
Cases: Serotype 2: Any Grade 1 1
Cases: Serotype 2: Grade I 1 1
Cases: Serotype 2: Grade II 0 0
Cases: Serotype 2: Grade III 0 0
Cases: Serotype 2: Grade IV 0 0
Cases: Serotype 3: Any Grade 1 0
Cases: Serotype 3: Grade I 0 0
Cases: Serotype 3: Grade II 1 0
Cases: Serotype 3: Grade III 0 0
Cases: Serotype 3: Grade IV 0 0
Cases: Serotype 4: Any Grade 1 2
Cases: Serotype 4: Grade I 0 1
Cases: Serotype 4: Grade II 1 1
Cases: Serotype 4: Grade III 0 0
Cases: Serotype 4: Grade IV 0 0
Cases: Unserotyped: Any Grade 0 0
Cases: Unserotyped: Grade I 0 0
Cases: Unserotyped: Grade II 0 0
Cases: Unserotyped: Grade III 0 0
Cases: Unserotyped: Grade IV 0 0
14.Primary Outcome
Title Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Hide Description Episodes were defined as the number of hospitalized virologically confirmed dengue episodes meeting WHO criteria. The WHO criteria was fever, any haemorrhagic manifestations, thrombocytopenia, plasma leakage or pleural effusion and/or ascites and/or hypoalbuminemia. Dengue haemorrhagic fever was graded as Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test. Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhages. Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness. Grade IV: Profound shock with undetectable blood pressure and pulse.
Time Frame Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on FupAS.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
Overall Number of Participants Analyzed 2131 1072
Measure Type: Number
Unit of Measure: Episodes
Episodes: Any of the 4 Serotypes: Any Grade 7 3
Episodes: Any of the 4 Serotypes: Grade I 1 2
Episodes: Any of the 4 Serotypes: Grade II 4 1
Episodes: Any of the 4 Serotypes: Grade III 2 0
Episodes: Any of the 4 Serotypes: Grade IV 0 0
Episodes: Serotype 1: Any Grade 5 0
Episodes: Serotype 1: Grade I 1 0
Episodes: Serotype 1: Grade II 2 0
Episodes: Serotype 1: Grade III 2 0
Episodes: Serotype 1: Grade IV 0 0
Episodes: Serotype 2: Any Grade 1 1
Episodes: Serotype 2: Grade I 1 1
Episodes: Serotype 2: Grade II 0 0
Episodes: Serotype 2: Grade III 0 0
Episodes: Serotype 2 Grade IV 0 0
Episodes: Serotype 3: Any Grade 1 0
Episodes: Serotype 3: Grade I 0 0
Episodes: Serotype 3: Grade II 1 0
Episodes: Serotype 3: Grade III 0 0
Episodes: Serotype 3: Grade IV 0 0
Episodes: Serotype 4: Any Grade 1 2
Episodes: Serotype 4: Grade I 0 1
Episodes: Serotype 4: Grade II 1 1
Episodes: Serotype 4: Grade III 0 0
Episodes: Serotype: 4 Grade IV 0 0
Episodes: Unserotyped: Any Grade 0 0
Episodes: Unserotyped: Grade I 0 0
Episodes: Unserotyped: Grade II 0 0
Episodes: Unserotyped: Grade III 0 0
Episodes: Unserotyped: Grade IV 0 0
Time Frame Adverse event data was collected throughout the study period (Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23)
Adverse Event Reporting Description This study involved a passive surveillance of hospitalized dengue cases and related and fatal serious adverse events in participants that participated in a previous study (CYD23). Non-serious adverse event data was not collected since no vaccine was administered in the present study. Analysis was performed on FupAS.
 
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23. Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
All-Cause Mortality
CYD Dengue Vaccine Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   3/2131 (0.14%)      2/1072 (0.19%)    
Show Serious Adverse Events Hide Serious Adverse Events
CYD Dengue Vaccine Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/2131 (0.14%)      2/1072 (0.19%)    
General disorders     
Drowning  1  0/2131 (0.00%)  0 1/1072 (0.09%)  1
Injury, poisoning and procedural complications     
Gun-shot wound  1  2/2131 (0.09%)  2 0/1072 (0.00%)  0
Road traffic accident  1  1/2131 (0.05%)  1 1/1072 (0.09%)  1
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CYD Dengue Vaccine Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director
Organization: Sanofi Pasteur SA
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01983553     History of Changes
Other Study ID Numbers: CYD57
U1111-1127-7380 ( Other Identifier: WHO )
First Submitted: November 6, 2013
First Posted: November 14, 2013
Results First Submitted: May 23, 2019
Results First Posted: July 29, 2019
Last Update Posted: August 27, 2019