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Trial record 1 of 1 for:    CYD63
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Immunogenicity and Safety of a Tetravalent Dengue Vaccine Booster Injection in Subjects Who Previously Completed a 3-dose Schedule

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ClinicalTrials.gov Identifier: NCT02824198
Recruitment Status : Completed
First Posted : July 6, 2016
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: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Dengue Fever
Dengue Hemorrhagic Fever
Interventions Biological: CYD Dengue Vaccine (5 dose formulation)
Biological: Placebo, NaCl 0.9%
Enrollment 118
Recruitment Details Study participants were enrolled from 01 July 2016 to 18 February 2017 at 3 sites in Singapore.
Pre-assignment Details A total of 118 participants who received 3 doses of CYD dengue vaccine in study CYD28 (NCT00880893) were enrolled and randomized in this study (CYD63). Results are reported based on the primary completion date of 18 March 2017.
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 a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63). Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).
Period Title: Overall Study
Started 89 29
Completed 88 28
Not Completed 1 1
Reason Not Completed
Protocol Violation             1             1
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 a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63). Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63). Total of all reporting groups
Overall Number of Baseline Participants 89 29 118
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 89 participants 29 participants 118 participants
<=18 years
11
  12.4%
0
   0.0%
11
   9.3%
Between 18 and 65 years
78
  87.6%
29
 100.0%
107
  90.7%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants 29 participants 118 participants
28.1  (11.18) 28.2  (9.18) 28.2  (10.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 29 participants 118 participants
Female
43
  48.3%
15
  51.7%
58
  49.2%
Male
46
  51.7%
14
  48.3%
60
  50.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD63 Compared to the Third CYD Dengue Vaccine Injection Received in Study CYD28: CYD Dengue Vaccine Booster Group
Hide Description 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 CYD28 and 28 days post-booster injection in CYD63
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 (CYD63). Here, ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28 CYD Dengue Vaccine Booster Group: Post Booster Dose
Hide Arm/Group Description:
Participants who received 3 doses of tetravalent dengue vaccine in previous study (CYD28) were enrolled in this study (CYD63).
Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
Overall Number of Participants Analyzed 75 75
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Dengue Virus Serotype 1 Number Analyzed 74 participants 75 participants
20.3
(13.9 to 29.5)
37.7
(26.4 to 53.7)
Dengue Virus Serotype 2 Number Analyzed 73 participants 75 participants
85.6
(55.7 to 132)
56.2
(38.5 to 82.1)
Dengue Virus Serotype 3 Number Analyzed 72 participants 75 participants
102
(78.4 to 133)
105
(77.4 to 142)
Dengue Virus Serotype 4 Number Analyzed 70 participants 75 participants
92.8
(72.5 to 119)
123
(93.8 to 161)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CYD Dengue Vaccine Booster Group: Post Dose 3 in CYD28, CYD Dengue Vaccine Booster Group: Post Booster Dose
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% 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 1.34
Confidence Interval (2-Sided) 95%
0.998 to 1.79
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 CYD28, CYD Dengue Vaccine Booster Group: Post Booster Dose
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 0.603
Confidence Interval (2-Sided) 95%
0.439 to 0.829
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 CYD28, CYD Dengue Vaccine Booster Group: Post Booster Dose
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 0.979
Confidence Interval (2-Sided) 95%
0.746 to 1.28
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 CYD28, CYD Dengue Vaccine Booster Group: Post Booster Dose
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 1.27
Confidence Interval (2-Sided) 95%
0.918 to 1.75
Estimation Comments [Not Specified]
2.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 a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).
Overall Number of Participants Analyzed 75 28
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Dengue Virus Serotype 1: Pre-booster Inj.
13.5
(9.31 to 19.6)
16.7
(7.73 to 36.1)
Dengue Virus Serotype 1: 28 days Post-booster Inj.
37.7
(26.4 to 53.7)
18.1
(8.61 to 38.1)
Dengue Virus Serotype 2: Pre-booster Inj.
18.4
(12.1 to 28.0)
23.2
(9.97 to 53.9)
Dengue Virus Serotype 2: 28 days Post-booster Inj.
56.2
(38.5 to 82.1)
21.5
(9.61 to 48.1)
Dengue Virus Serotype 3: Pre-booster Inj.
22.4
(15.6 to 32.0)
27.4
(14.8 to 51.0)
Dengue Virus Serotype 3: 28 days Post-booster Inj.
105
(77.4 to 142)
24.1
(13.6 to 42.6)
Dengue Virus Serotype 4: Pre-booster Inj.
28.0
(20.4 to 38.5)
44.9
(28.3 to 71.3)
Dengue Virus Serotype 4: 28 days Post-booster Inj.
123
(93.8 to 161)
39.8
(23.9 to 66.3)
3.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 a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).
Overall Number of Participants Analyzed 75 28
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Dengue Virus Serotype 1
1.74
(1.33 to 2.28)
0.676
(0.525 to 0.871)
Dengue Virus Serotype 2
2.04
(1.54 to 2.69)
0.624
(0.523 to 0.745)
Dengue Virus Serotype 3
3.52
(2.58 to 4.82)
0.669
(0.513 to 0.873)
Dengue Virus Serotype 4
3.58
(2.61 to 4.90)
0.822
(0.640 to 1.06)
4.Secondary Outcome
Title Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, 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 CYD28 and 28 days post-booster injection in CYD63
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 a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).
Overall Number of Participants Analyzed 75 28
Measure Type: Number
Unit of Measure: Percentage of participants
Dengue Virus Serotype 1: 28 days Post-dose 3 Number Analyzed 74 participants 28 participants
52.7 50.0
Dengue Virus Serotype 1: 28 days Post-booster Inj. Number Analyzed 75 participants 28 participants
74.7 35.7
Dengue Virus Serotype 2: 28 days Post-dose 3 Number Analyzed 73 participants 27 participants
89.0 74.1
Dengue Virus Serotype 2: 28 days Post-booster Inj. Number Analyzed 75 participants 28 participants
81.3 42.9
Dengue Virus Serotype 3: 28 days Post-dose 3 Number Analyzed 72 participants 27 participants
97.2 96.3
Dengue Virus Serotype 3: 28 days Post-booster Inj. Number Analyzed 75 participants 28 participants
96.0 67.9
Dengue Virus Serotype 4: 28 days Post-dose 3 Number Analyzed 70 participants 26 participants
95.7 88.5
Dengue Virus Serotype 4: 28 days Post-booster Inj. Number Analyzed 75 participants 28 participants
97.3 82.1
5.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 a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).
Overall Number of Participants Analyzed 75 28
Measure Type: Number
Unit of Measure: Percentage of participants
Dengue Virus Serotype 1: Pre-booster Inj. 32.0 32.1
Dengue Virus Serotype 1: 28 days Post-booster Inj. 74.7 35.7
Dengue Virus Serotype 2: Pre-booster Inj. 41.3 42.9
Dengue Virus Serotype 2: 28 days Post-booster Inj. 81.3 42.9
Dengue Virus Serotype 3: Pre-booster Inj. 58.7 60.7
Dengue Virus Serotype 3: 28 days Post-booster Inj. 96.0 67.9
Dengue Virus Serotype 4: Pre-booster Inj. 70.7 89.3
Dengue Virus Serotype 4: 28 days Post-booster Inj. 97.3 82.1
6.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 rates for each serotypes were defined as the percentages of participants with either a pre-booster titer < 10 (1/dil) and a post-booster titer >= 40 (1/dil), or a pre-booster titer >=10 (1/dil) 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 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 a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).
Overall Number of Participants Analyzed 75 28
Measure Type: Number
Unit of Measure: Percentage of participants
Dengue Virus Serotype 1 29.3 3.6
Dengue Virus Serotype 2 29.3 0.0
Dengue Virus Serotype 3 44.0 0.0
Dengue Virus Serotype 4 38.7 0.0
7.Secondary Outcome
Title GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63
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 CYD28 and pre-booster injection (Day 0) in CYD 63
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 a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).
Overall Number of Participants Analyzed 75 28
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Dengue Virus Serotype 1: 28 days Post-dose 3 Number Analyzed 74 participants 28 participants
20.3
(13.9 to 29.5)
26.8
(12.4 to 57.7)
Dengue Virus Serotype 1: Pre-booster Inj. Number Analyzed 75 participants 28 participants
13.5
(9.31 to 19.6)
16.7
(7.73 to 36.1)
Dengue Virus Serotype 2: 28 days Post-dose 3 Number Analyzed 73 participants 27 participants
85.6
(55.7 to 132)
65.4
(28.3 to 151)
Dengue Virus Serotype 2: Pre-booster Inj. Number Analyzed 75 participants 28 participants
18.4
(12.1 to 28.0)
23.2
(9.97 to 53.9)
Dengue Virus Serotype 3: 28 days Post-dose 3 Number Analyzed 72 participants 27 participants
102
(78.4 to 133)
107
(63.6 to 179)
Dengue Virus Serotype 3: Pre-booster Inj. Number Analyzed 75 participants 28 participants
22.4
(15.6 to 32.0)
27.4
(14.8 to 51.0)
Dengue Virus Serotype 4: 28 days Post-dose 3 Number Analyzed 70 participants 26 participants
92.8
(72.5 to 119)
86.5
(51.0 to 147)
Dengue Virus Serotype 4: Pre-booster Inj. Number Analyzed 75 participants 28 participants
28.0
(20.4 to 38.5)
44.9
(28.3 to 71.3)
8.Secondary Outcome
Title GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28 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 CYD28 and pre-booster injection (Day 0) in CYD63
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 a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).
Overall Number of Participants Analyzed 75 28
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
Dengue Virus Serotype 1 Number Analyzed 74 participants 28 participants
0.487
(0.390 to 0.609)
0.441
(0.316 to 0.617)
Dengue Virus Serotype 2 Number Analyzed 73 participants 27 participants
0.199
(0.160 to 0.248)
0.313
(0.224 to 0.437)
Dengue Virus Serotype 3 Number Analyzed 72 participants 27 participants
0.207
(0.163 to 0.262)
0.267
(0.171 to 0.416)
Dengue Virus Serotype 4 Number Analyzed 70 participants 26 participants
0.291
(0.217 to 0.391)
0.474
(0.343 to 0.656)
9.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. 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 a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).
Overall Number of Participants Analyzed 89 29
Measure Type: Number
Unit of Measure: Participants
Injection-site Pain: Any Number Analyzed 88 participants 28 participants
29 7
Injection-site Pain: Grade 3 Number Analyzed 88 participants 28 participants
1 0
Injection-site Erythema: Any Number Analyzed 88 participants 28 participants
1 0
Injection-site Erythema: Grade 3 Number Analyzed 88 participants 28 participants
0 0
Injection-site Swelling: Any Number Analyzed 88 participants 28 participants
0 0
Injection-site Swelling: Grade 3 Number Analyzed 88 participants 28 participants
0 0
10.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 a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63).
Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).
Overall Number of Participants Analyzed 89 29
Measure Type: Number
Unit of Measure: Participants
Fever: Any Grade Number Analyzed 88 participants 28 participants
2 0
Fever: Grade 3 Number Analyzed 88 participants 28 participants
0 0
Headache: Any Grade Number Analyzed 88 participants 28 participants
23 3
Headache: Grade 3 Number Analyzed 88 participants 28 participants
0 0
Malaise: Any Grade Number Analyzed 88 participants 28 participants
11 3
Malaise: Grade 3 Number Analyzed 88 participants 28 participants
0 1
Myalgia: Any Grade Number Analyzed 88 participants 28 participants
21 7
Myalgia: Grade 3 Number Analyzed 88 participants 28 participants
0 1
Asthenia: Any Grade Number Analyzed 88 participants 28 participants
15 4
Asthenia: Grade 3 Number Analyzed 88 participants 28 participants
0 0
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 a previous CYD dengue vaccine study (CYD28), received a booster injection of CYD dengue vaccine at Day 0 in this study (CYD63). Participants who received 3 doses of the tetravalent dengue vaccine in a previous CYD dengue vaccine study (CYD28), received an injection of a placebo at Day 0 in this study (CYD63).
All-Cause Mortality
CYD Dengue Vaccine Booster Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/89 (0.00%)      0/29 (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   1/89 (1.12%)      0/29 (0.00%)    
Injury, poisoning and procedural complications     
Road Traffic Accident  1  1/89 (1.12%)  1 0/29 (0.00%)  0
1
Term from vocabulary, MedDRA version 18.0
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 Booster Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   47/89 (52.81%)      10/29 (34.48%)    
General disorders     
Asthenia  1  15/89 (16.85%)  15 4/29 (13.79%)  4
Injection Site Pain  1  29/89 (32.58%)  29 7/29 (24.14%)  7
Malaise  1  11/89 (12.36%)  11 3/29 (10.34%)  3
Infections and infestations     
Upper Respiratory Tract Infection  1  6/89 (6.74%)  7 1/29 (3.45%)  1
Musculoskeletal and connective tissue disorders     
Myalgia  1  21/89 (23.60%)  21 7/29 (24.14%)  7
Nervous system disorders     
Headache  1  23/89 (25.84%)  23 4/29 (13.79%)  4
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 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
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: NCT02824198     History of Changes
Other Study ID Numbers: CYD63
U1111-1161-2813 ( Other Identifier: WHO )
First Submitted: July 1, 2016
First Posted: July 6, 2016
Results First Submitted: May 24, 2019
Results First Posted: June 14, 2019
Last Update Posted: June 14, 2019