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Trial record 1 of 1 for:    CYD64
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Study of a Booster Dose of a Tetravalent Dengue Vaccine in Subjects Who Previously Completed the 3-dose Schedule

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ClinicalTrials.gov Identifier: NCT02623725
Recruitment Status : Completed
First Posted : December 8, 2015
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Dengue Fever
Dengue Hemorrhagic Fever
Interventions Biological: CYD Dengue Vaccine (5-dose formulation)
Biological: Placebo, NaCl 0.9%
Enrollment 251
Recruitment Details Study participants were enrolled from 14 April 2016 to 19 October 2016 at 5 sites, one each in Brazil, Colombia, Honduras, Mexico, and Puerto Rico.
Pre-assignment Details A total of 251 participants who received 3 doses of CYD dengue vaccine in previous studies CYD13 (NCT00993447) and CYD30 (NCT01187433) were enrolled and randomized in this study (CYD64). Results are reported based on the primary completion date of 23 November 2016.
Arm/Group Title CYD Dengue Vaccine Booster Group Placebo Group
Hide Arm/Group Description Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64). Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).
Period Title: Overall Study
Started 187 64
Completed 186 64
Not Completed 1 0
Reason Not Completed
Protocol Violation             1             0
Arm/Group Title CYD Dengue Vaccine Booster Group Placebo Group Total
Hide Arm/Group Description Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64). Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64). Total of all reporting groups
Overall Number of Baseline Participants 187 64 251
Hide Baseline Analysis Population Description
Analysis was performed on all randomized participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 187 participants 64 participants 251 participants
<=18 years
63
  33.7%
19
  29.7%
82
  32.7%
Between 18 and 65 years
124
  66.3%
45
  70.3%
169
  67.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 187 participants 64 participants 251 participants
19.2  (2.14) 19.0  (1.99) 19.1  (2.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 187 participants 64 participants 251 participants
Female
89
  47.6%
27
  42.2%
116
  46.2%
Male
98
  52.4%
37
  57.8%
135
  53.8%
1.Primary Outcome
Title Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group
Hide Description Geometric Mean Titers (GMTs) of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the plaque reduction neutralization test (PRNT).
Time Frame 28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Per-Protocol Analysis Set which included all participants who had no protocol deviations from the present study (CYD64). Here, ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64
Hide Arm/Group Description:
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64).
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
Overall Number of Participants Analyzed 177 177
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Dengue Virus Serotype 1 Number Analyzed 176 participants 177 participants
316
(233 to 428)
560
(421 to 744)
Dengue Virus Serotype 2 Number Analyzed 175 participants 177 participants
356
(275 to 462)
657
(520 to 830)
Dengue Virus Serotype 3 Number Analyzed 175 participants 177 participants
640
(516 to 794)
671
(535 to 843)
Dengue Virus Serotype 4 Number Analyzed 176 participants 177 participants
243
(195 to 303)
344
(279 to 424)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30, CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64
Comments Dengue Virus Serotype 1
Type of Statistical Test Non-Inferiority
Comments The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95 percent (%) Confidence Interval (CI) of the Geometric mean of titer ratios (GMTRs) (booster vs post-dose 3) was greater than (>) 1/2 for each serotype.
Method of Estimation Estimation Parameter Geometric mean of titer ratio
Estimated Value 1.66
Confidence Interval (2-Sided) 95%
1.33 to 2.06
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30, CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64
Comments Dengue Virus Serotype 2
Type of Statistical Test Non-Inferiority
Comments The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was > 1/2 for each serotype.
Method of Estimation Estimation Parameter Geometric mean of titer ratio
Estimated Value 1.82
Confidence Interval (2-Sided) 95%
1.43 to 2.31
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30, CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64
Comments Dengue Virus Serotype 3
Type of Statistical Test Non-Inferiority
Comments The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was > 1/2 for each serotype.
Method of Estimation Estimation Parameter Geometric mean of titer ratio
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.841 to 1.27
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30, CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64
Comments Dengue Virus Serotype 4
Type of Statistical Test Non-Inferiority
Comments The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was > 1/2 for each serotype.
Method of Estimation Estimation Parameter Geometric mean of titer ratio
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
1.01 to 1.74
Estimation Comments [Not Specified]
2.Secondary Outcome
Title GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group
Hide Description GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT.
Time Frame 28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set which included all participants who received either CYD Dengue Vaccine or placebo and had blood sample drawn and valid post-injection serology results. Here, ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30 CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64
Hide Arm/Group Description:
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30) were included in this study (CYD64).
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
Overall Number of Participants Analyzed 184 184
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Dengue Virus Serotype 1 Number Analyzed 183 participants 184 participants
304
(225 to 409)
538
(406 to 714)
Dengue Virus Serotype 2 Number Analyzed 182 participants 184 participants
338
(261 to 436)
648
(515 to 817)
Dengue Virus Serotype 3 Number Analyzed 182 participants 184 participants
617
(499 to 762)
660
(528 to 827)
Dengue Virus Serotype 4 Number Analyzed 183 participants 184 participants
241
(195 to 298)
341
(278 to 418)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30, CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64
Comments Dengue Virus Serotype 1
Type of Statistical Test Superiority
Comments The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was > 1.
Method of Estimation Estimation Parameter Geometric mean of titer ratio
Estimated Value 1.66
Confidence Interval (2-Sided) 95%
1.34 to 2.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30, CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64
Comments Dengue Virus Serotype 2
Type of Statistical Test Superiority
Comments The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was > 1.
Method of Estimation Estimation Parameter Geometric mean of titer ratio
Estimated Value 1.89
Confidence Interval (2-Sided) 95%
1.49 to 2.41
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30, CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64
Comments Dengue Virus Serotype 3
Type of Statistical Test Superiority
Comments The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was > 1.
Method of Estimation Estimation Parameter Geometric mean of titer ratio
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.860 to 1.30
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Booster Group:Post Dose 3 in CYD13 or CYD30, CYD Dengue Vaccine Booster Group: Post Booster Dose in CYD64
Comments Dengue Virus Serotype 4
Type of Statistical Test Superiority
Comments The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was > 1.
Method of Estimation Estimation Parameter Geometric mean of titer ratio
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
1.02 to 1.73
Estimation Comments [Not Specified]
3.Secondary Outcome
Title GMTs of Antibodies Against Each Dengue Virus Serotype Before And Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo
Hide Description GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT.
Time Frame Pre-booster injection (Day 0) and 28 days post-booster injection
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Per-Protocol Analysis Set.
Arm/Group Title CYD Dengue Vaccine Booster Group Placebo Group
Hide Arm/Group Description:
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).
Overall Number of Participants Analyzed 177 64
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Dengue Virus Serotype 1: Pre-booster Inj.
325
(233 to 452)
349
(201 to 607)
Dengue Virus Serotype 1: 28 days Post-booster Inj.
560
(421 to 744)
297
(162 to 547)
Dengue Virus Serotype 2: Pre-booster Inj.
360
(267 to 484)
323
(195 to 535)
Dengue Virus Serotype 2: 28 days Post-booster Inj.
657
(520 to 830)
354
(205 to 610)
Dengue Virus Serotype 3: Pre-booster Inj.
357
(269 to 472)
442
(270 to 724)
Dengue Virus Serotype 3: 28 days Post-booster Inj.
671
(535 to 843)
432
(266 to 700)
Dengue Virus Serotype 4: Pre-booster Inj.
162
(134 to 195)
161
(108 to 242)
Dengue Virus Serotype 4: 28 days Post-booster Inj.
344
(279 to 424)
161
(110 to 237)
4.Secondary Outcome
Title GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo
Hide Description GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT.
Time Frame Pre-booster injection (Day 0) and 28 days post-booster injection
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Per-Protocol Analysis Set.
Arm/Group Title CYD Dengue Vaccine Booster Group Placebo Group
Hide Arm/Group Description:
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).
Overall Number of Participants Analyzed 177 64
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Dengue Virus Serotype 1
1.59
(1.33 to 1.90)
0.798
(0.623 to 1.02)
Dengue Virus Serotype 2
1.70
(1.43 to 2.03)
1.03
(0.754 to 1.40)
Dengue Virus Serotype 3
1.78
(1.47 to 2.16)
0.946
(0.749 to 1.19)
Dengue Virus Serotype 4
2.09
(1.65 to 2.63)
0.946
(0.777 to 1.15)
5.Secondary Outcome
Title Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers >=10 (1/dilution).
Time Frame 28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64
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 Booster Group Placebo Group
Hide Arm/Group Description:
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).
Overall Number of Participants Analyzed 177 64
Measure Type: Number
Unit of Measure: Percentage of participants
Dengue Virus Serotype 1: 28 days Post-dose 3 Number Analyzed 176 participants 64 participants
90.9 90.6
Dengue Virus Serotype 1: 28 days Post-booster Inj. Number Analyzed 177 participants 64 participants
96.0 84.4
Dengue Virus Serotype 2: 28 days Post-dose 3 Number Analyzed 175 participants 64 participants
95.4 96.9
Dengue Virus Serotype 2: 28 days Post-booster Inj. Number Analyzed 177 participants 64 participants
98.9 87.5
Dengue Virus Serotype 3: 28 days Post-dose 3 Number Analyzed 175 participants 64 participants
100.0 100.0
Dengue Virus Serotype 3: 28 days Post-booster Inj. Number Analyzed 177 participants 64 participants
99.4 95.3
Dengue Virus Serotype 4: 28 days Post-dose 3 Number Analyzed 176 participants 63 participants
92.0 96.8
Dengue Virus Serotype 4: 28 days Post-booster Inj. Number Analyzed 177 participants 64 participants
100.0 93.8
6.Secondary Outcome
Title Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo
Hide Description Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing Antibody titers >=10 (1/dilution).
Time Frame Pre-booster injection (Day 0) and 28 days post-booster injection
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Per-Protocol Analysis Set.
Arm/Group Title CYD Dengue Vaccine Booster Group Placebo Group
Hide Arm/Group Description:
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).
Overall Number of Participants Analyzed 177 64
Measure Type: Number
Unit of Measure: Percentage of participants
Dengue Virus Serotype 1: Pre-booster Inj. 88.1 90.6
Dengue Virus Serotype 1: 28 days Post-booster Inj. 96.0 84.4
Dengue Virus Serotype 2: Pre-booster Inj. 89.8 90.6
Dengue Virus Serotype 2: 28 days Post-booster Inj. 98.9 87.5
Dengue Virus Serotype 3: Pre-booster Inj. 92.1 95.3
Dengue Virus Serotype 3: 28 days Post-booster Inj. 99.4 95.3
Dengue Virus Serotype 4: Pre-booster Inj. 97.2 92.2
Dengue Virus Serotype 4: 28 days Post-booster Inj. 100.0 93.8
7.Secondary Outcome
Title Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo
Hide Description Seroconversion for each serotype was defined as the percentage of participants with either a pre-booster titer < 10 (1/dilution) and a post-booster titer >= 40 (1/dilution), or a pre-booster titer >=10 (1/dilution) and a >= 4-fold increase in post-booster titer as determined by PRNT.
Time Frame 28 days post-booster injection
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Booster Group Placebo Group
Hide Arm/Group Description:
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).
Overall Number of Participants Analyzed 184 64
Measure Type: Number
Unit of Measure: Percentage of participants
Dengue Virus Serotype 1 17.9 3.1
Dengue Virus Serotype 2 20.1 17.2
Dengue Virus Serotype 3 21.2 4.7
Dengue Virus Serotype 4 20.7 6.3
8.Secondary Outcome
Title GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo
Hide Description GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the PRNT.
Time Frame 28 days post-dose 3 in CYD13 or CYD30 and pre-booster injection (Day 0) in CYD64
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 Booster Group Placebo Group
Hide Arm/Group Description:
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).
Overall Number of Participants Analyzed 177 64
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Dengue Virus Serotype 1: 28 days Post-dose 3 Number Analyzed 176 participants 64 participants
316
(233 to 428)
232
(142 to 381)
Dengue Virus Serotype 1: Pre-booster Inj. Number Analyzed 177 participants 64 participants
325
(233 to 452)
349
(201 to 607)
Dengue Virus Serotype 2: 28 days Post-dose 3 Number Analyzed 175 participants 64 participants
356
(275 to 462)
303
(210 to 438)
Dengue Virus Serotype 2: Pre-booster Inj. Number Analyzed 177 participants 64 participants
360
(267 to 484)
323
(195 to 535)
Dengue Virus Serotype 3: 28 days Post-dose 3 Number Analyzed 175 participants 64 participants
640
(516 to 794)
541
(372 to 785)
Dengue Virus Serotype 3: Pre-booster Inj. Number Analyzed 177 participants 64 participants
357
(269 to 472)
442
(270 to 724)
Dengue Virus Serotype 4: 28 days Post-dose 3 Number Analyzed 176 participants 63 participants
243
(195 to 303)
255
(192 to 340)
Dengue Virus Serotype 4: Pre-booster Inj. Number Analyzed 177 participants 64 participants
162
(134 to 195)
161
(108 to 242)
9.Secondary Outcome
Title GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo
Hide Description GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the PRNT.
Time Frame 28 days post-dose 3 in CYD13 or CYD30 and pre-booster injection (Day 0) in CYD64
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 Booster Group Placebo Group
Hide Arm/Group Description:
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).
Overall Number of Participants Analyzed 177 64
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Dengue Virus Serotype 1 Number Analyzed 176 participants 64 participants
0.952
(0.765 to 1.18)
1.41
(0.927 to 2.14)
Dengue Virus Serotype 2 Number Analyzed 175 participants 64 participants
0.986
(0.778 to 1.25)
1.04
(0.662 to 1.65)
Dengue Virus Serotype 3 Number Analyzed 175 participants 64 participants
0.536
(0.440 to 0.654)
0.818
(0.574 to 1.16)
Dengue Virus Serotype 4 Number Analyzed 176 participants 63 participants
0.618
(0.497 to 0.770)
0.613
(0.427 to 0.881)
10.Secondary Outcome
Title Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo
Hide Description Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions: Pain: significant; prevents daily activity; Erythema and Swelling: > 100 mm.
Time Frame Within 7 days after booster injection
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety Analysis Set which included all participants who received either CYD dengue vaccine or placebo.
Arm/Group Title CYD Dengue Vaccine Booster Group Placebo Group
Hide Arm/Group Description:
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).
Overall Number of Participants Analyzed 187 64
Measure Type: Number
Unit of Measure: Participants
Injection-site Pain: Any 46 12
Injection-site Pain: Grade 3 1 0
Injection-site Erythema: Any 1 0
Injection-site Erythema: Grade 3 0 0
Injection-site Swelling: Any 0 0
Injection-site Swelling: Grade 3 0 0
11.Secondary Outcome
Title Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo
Hide Description Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: >= 39°C; Headache, Malaise, Myalgia, and Asthenia: significant, prevents daily activity.
Time Frame Within 14 days after booster injection
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety Analysis Set. Here, ‘number analyzed’ = participants with available data for specified category.
Arm/Group Title CYD Dengue Vaccine Booster Group Placebo Group
Hide Arm/Group Description:
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64).
Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).
Overall Number of Participants Analyzed 187 64
Measure Type: Number
Unit of Measure: Participants
Fever: Any Grade Number Analyzed 179 participants 63 participants
13 6
Fever: Grade 3 Number Analyzed 179 participants 63 participants
1 1
Headache: Any Grade Number Analyzed 187 participants 64 participants
87 22
Headache: Grade 3 Number Analyzed 187 participants 64 participants
11 2
Malaise: Any Grade Number Analyzed 187 participants 64 participants
47 19
Malaise: Grade 3 Number Analyzed 187 participants 64 participants
5 0
Myalgia: Any Grade Number Analyzed 187 participants 64 participants
60 19
Myalgia: Grade 3 Number Analyzed 187 participants 64 participants
2 2
Asthenia: Any Grade Number Analyzed 187 participants 64 participants
52 14
Asthenia: Grade 3 Number Analyzed 187 participants 64 participants
3 1
Time Frame Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-booster injection. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study: only SAE data occurred within 28 days after booster-injection were reported for primary analysis.
Adverse Event Reporting Description Analysis was performed on Safety Analysis Set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
 
Arm/Group Title CYD Dengue Vaccine Booster Group Placebo Group
Hide Arm/Group Description Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD64). Participants who received 3 doses of the tetravalent dengue vaccine in previous CYD dengue vaccine studies (CYD13 or CYD30), received an injection of placebo at Day 0 in this study (CYD64).
All-Cause Mortality
CYD Dengue Vaccine Booster Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/187 (0.00%)      0/64 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
CYD Dengue Vaccine Booster Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/187 (0.00%)      0/64 (0.00%)    
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 Booster Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   115/187 (61.50%)      31/64 (48.44%)    
General disorders     
Asthenia  1  52/187 (27.81%)  52 14/64 (21.88%)  14
Injection Site Pain  1  46/187 (24.60%)  46 12/64 (18.75%)  12
Malaise  1  47/187 (25.13%)  48 19/64 (29.69%)  19
Pyrexia  1  15/187 (8.02%)  15 6/64 (9.38%)  6
Musculoskeletal and connective tissue disorders     
Myalgia  1  60/187 (32.09%)  61 19/64 (29.69%)  19
Nervous system disorders     
Headache  1  88/187 (47.06%)  90 22/64 (34.38%)  23
1
Term from vocabulary, MedDRA version 18.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur
Phone: 800-633-1610 ext ext 1#
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT02623725     History of Changes
Other Study ID Numbers: CYD64
U1111-1161-2855 ( Other Identifier: WHO )
First Submitted: December 3, 2015
First Posted: December 8, 2015
Results First Submitted: May 24, 2019
Results First Posted: June 14, 2019
Last Update Posted: June 14, 2019