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Study of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India

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ClinicalTrials.gov Identifier: NCT01550289
Recruitment Status : Completed
First Posted : March 9, 2012
Results First Posted : November 3, 2016
Last Update Posted : December 28, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Dengue
Dengue Fever
Dengue Hemorrhagic Fever
Interventions Biological: Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus
Biological: Placebo: NaCl 0.9% solution
Enrollment 189
Recruitment Details Study participants were enrolled from 27 March 2012 to 28 June 2012 at 5 clinical centers in India.
Pre-assignment Details A total of 189 participants who met all inclusion and no exclusion criteria were randomized and vaccinated in this trial; 187 were included in the Full Analysis Set.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. Healthy adult participants received 3 vaccinations of placebo vaccine.
Period Title: Overall Study
Started 128 61
Completed 115 57
Not Completed 13 4
Reason Not Completed
Protocol Violation             1             0
Lost to Follow-up             1             1
Withdrawal by Subject             11             3
Arm/Group Title CYD Dengue Vaccine Group Placebo Group Total
Hide Arm/Group Description Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. Healthy adult participants received 3 vaccinations of placebo vaccine. Total of all reporting groups
Overall Number of Baseline Participants 126 61 187
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 61 participants 187 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
126
 100.0%
61
 100.0%
187
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 126 participants 61 participants 187 participants
29.5  (7.17) 29.6  (6.41) 29.5  (6.91)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 126 participants 61 participants 187 participants
Female
27
  21.4%
9
  14.8%
36
  19.3%
Male
99
  78.6%
52
  85.2%
151
  80.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
India Number Analyzed 126 participants 61 participants 187 participants
126
 100.0%
61
 100.0%
187
 100.0%
1.Primary Outcome
Title Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Hide Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
Healthy adult participants received 3 vaccinations of placebo vaccine.
Overall Number of Participants Analyzed 126 61
Measure Type: Number
Unit of Measure: Percentage of participants
Serotype 1; Pre-injection 1 (N=126, 61) 83.3 80.3
Serotype 1; Post-injection 1 (N=125, 61) 91.2 83.6
Serotype 1; Post-injection 2 (N=117, 58) 94.9 81.0
Serotype 1; Post-injection 3 (N=115, 57) 97.4 87.7
Serotype 2; Pre-injection 1 (N=126, 61) 83.3 86.9
Serotype 2; Post-injection 1 (N=126, 61) 94.4 88.5
Serotype 2; Post-injection 2 (N=117, 58) 99.1 84.5
Serotype 2; Post-injection 3 (N=115, 57) 97.4 91.2
Serotype 3; Pre-injection 1 (N=126, 61) 84.9 86.9
Serotype 3; Post-injection 1 (N=126, 61) 98.4 90.2
Serotype 3; Post-injection 2 (N=117, 58) 98.3 84.5
Serotype 3; Post-injection 3 (N=115, 57) 99.1 89.5
Serotype 4; Pre-injection 1 (N=126, 61) 77.0 80.3
Serotype 4; Post-injection 1 (N=126, 61) 96.0 85.2
Serotype 4; Post-injection 2 (N=117, 57) 99.1 78.9
Serotype 4; Post-injection 3 (N=115, 57) 100.0 84.2
2.Primary Outcome
Title Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Hide Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
Healthy adult participants received 3 vaccinations of placebo vaccine.
Overall Number of Participants Analyzed 126 61
Measure Type: Number
Unit of Measure: Percentage of participants
At least 1 serotype; Pre-injection 1 (N=126, 61) 86.5 88.5
At least 1 serotype; Post-injection 1 (N=126, 61) 99.2 90.2
At least 1 serotype; Post-injection 2 (N=117, 58) 100.0 86.2
At least 1 serotype; Post-injection 3 (N=115, 57) 100.0 91.2
At least 2 serotypes; Pre-injection 1 (N=126, 61) 84.1 85.2
At least 2 serotypes; Post-injection 1 (N=126, 61) 98.4 88.5
At least 2 serotypes; Post-injection 2 (N=117, 58) 98.3 82.8
At least 2 serotypes; Post-injection 3 (N=115, 57) 99.1 89.5
At least 3 serotypes; Pre-injection 1 (N=126, 61) 82.5 83.6
At least 3 serotypes; Post-injection 1 (N=126, 61) 92.1 88.5
At least 3 serotypes; Post-injection 2 (N=117, 58) 98.3 81.0
At least 3 serotypes; Post-injection 3 (N=115, 57) 97.4 87.7
All 4 serotypes; Pre-injection 1 (N=126, 61) 75.4 77.0
All 4 serotypes; Post-injection 1 (N=126, 61) 89.7 80.3
All 4 serotypes; Post-injection 2 (N=117, 58) 94.9 77.6
All 4 serotypes; Post-injection 3 (N=115, 57) 97.4 84.2
3.Primary Outcome
Title Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Hide Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
Healthy adult participants received 3 vaccinations of placebo vaccine.
Overall Number of Participants Analyzed 126 61
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilutions)
Serotype 1; Pre-injection 1 (N=126, 61)
184
(127 to 268)
234
(133 to 409)
Serotype 1; Post-injection 1 (N=125, 61)
605
(410 to 892)
288
(161 to 513)
Serotype 1; Post-injection 2 (N=117, 58)
556
(391 to 790)
294
(159 to 543)
Serotype 1; Post-injection 3 (N=115, 57)
461
(340 to 625)
268
(164 to 438)
Serotype 2; Pre-injection 1 (N=126, 61)
204
(141 to 294)
243
(147 to 403)
Serotype 2; Post-injection 1 (N=126, 61)
720
(510 to 1015)
300
(184 to 489)
Serotype 2; Post-injection 2 (N=117, 58)
787
(592 to 1045)
288
(163 to 509)
Serotype 2; Post-injection 3 (N=115, 57)
484
(370 to 634)
258
(163 to 410)
Serotype 3; Pre-injection 1 (N=126, 61)
219
(153 to 312)
216
(131 to 354)
Serotype 3; Post-injection 1 (N=126, 61)
951
(691 to 1309)
293
(180 to 478)
Serotype 3; Post-injection 2 (N=117, 58)
846
(635 to 1127)
249
(143 to 434)
Serotype 3; Post-injection 3 (N=115, 57)
709
(552 to 911)
268
(168 to 426)
Serotype 4; Pre injection 1 (N=126, 61)
55.4
(41.4 to 74.2)
62.0
(42.0 to 91.5)
Serotype 4; Post-injection 1 (N=126, 61)
358
(271 to 472)
78.7
(52.7 to 117)
Serotype 4; Post-injection 2 (N=117, 57)
289
(236 to 354)
72.8
(46.6 to 114)
Serotype 4; Post-injection 3 (N=115, 57)
336
(271 to 417)
91.9
(60.8 to 139)
4.Primary Outcome
Title Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Hide Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titer ratios were assessed in the Full Analysis Set with available data for each time point.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
Healthy adult participants received 3 vaccinations of placebo vaccine.
Overall Number of Participants Analyzed 126 61
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer ratio
Serotype 1; Post-inj. 1/Pre-inj. 1 (N=125,61)
3.23
(2.49 to 4.18)
1.23
(1.02 to 1.49)
Serotype 1; Post-inj. 2/Pre-inj. 1 (N=117,58)
3.15
(2.46 to 4.04)
1.26
(1.01 to 1.58)
Serotype 1; Post-inj. 3/Pre-inj. 1 (N=115,57)
2.64
(2.08 to 3.35)
1.18
(0.838 to 1.66)
Serotype 2; Post-inj. 1/Pre-inj. 1 (N=126,61)
3.53
(2.76 to 4.52)
1.23
(1.03 to 1.47)
Serotype 2; Post-inj. 2/Pre-inj. 1 (N=117,58)
3.83
(2.84 to 5.18)
1.17
(0.951 to 1.45)
Serotype 2; Post-inj. 3/Pre-inj. 1 (N=115,57)
2.38
(1.81 to 3.11)
1.05
(0.791 to 1.41)
Serotype 3; Post-inj. 1/Pre-inj. 1 (N=126,61)
4.35
(3.34 to 5.68)
1.36
(1.09 to 1.69)
Serotype 3; Post-inj. 2/Pre-inj. 1 (N=117,58)
3.97
(2.99 to 5.28)
1.13
(0.888 to 1.44)
Serotype 3; Post-inj. 3/Pre-inj. 1 (N=115,57)
3.39
(2.61 to 4.40)
1.22
(0.869 to 1.72)
Serotype 4; Post-inj. 1/Pre-inj. 1 (N=126,61)
6.46
(4.74 to 8.79)
1.27
(1.00 to 1.61)
Serotype 4; Post-inj. 2/Pre-inj. 1 (N=117,57)
5.16
(3.98 to 6.68)
1.15
(0.920 to 1.45)
Serotype 4; Post-inj. 3/Pre-inj. 1 (N=115,57)
6.11
(4.81 to 7.77)
1.44
(1.09 to 1.90)
5.Primary Outcome
Title Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Hide Description Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain Significant; prevents daily activities; Erythema and Swelling >100 mm. Grade 3 Solicited systemic reactions: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Asthenia Significant; prevents daily activities.
Time Frame Day 0 up to Day 14 post each injection
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set with available data for each time point.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
Healthy adult participants received 3 vaccinations of placebo vaccine.
Overall Number of Participants Analyzed 127 61
Measure Type: Number
Unit of Measure: Percentage of participants
Injection-site Pain; Post-Any inj. (N=126, 61) 9.5 4.9
Grade 3 Inj.-site Pain; Post-Any inj. (N=126, 61) 0.0 0.0
Injection-site Erythema; Post-Any inj. (N=126, 61) 0.0 0.0
Grade 3 Inj.-site Erythema;Post-Any inj (N=126,61) 0.0 0.0
Injection-site Swelling; Post-Any inj. (N=126, 61) 0.0 0.0
Grade 3 Inj.-site Swelling;PostAny inj (N=126,61) 0.0 0.0
Injection-site Pain; Post-inj. 1 (N=126, 61) 6.3 4.9
Grade 3 Inj.-site Pain; Post-inj. 1 (N=126, 61) 0.0 0.0
Injection-site Erythema; Post-inj. 1 (N=126, 61) 0.0 0.0
Grade 3 Inj.-site Erythema; Post-inj 1 (N=126,61) 0.0 0.0
Injection-site Swelling; Post-inj. 1 (N=126, 61) 0.0 0.0
Grade 3 Inj.-site Swelling; Post-inj. 1 (N=126,61) 0.0 0.0
Injection-site Pain; Post-inj. 2 (N=117, 58) 1.7 3.4
Grade 3 Inj.-site Pain; Post-inj. 2 (N=117, 58) 0.0 0.0
Injection-site Erythema; Post-inj. 2 (N=117, 58) 0.0 0.0
Grade 3 Inj.-site Erythema; Post-inj 2 (N=117,58) 0.0 0.0
Injection-site Swelling; Post-inj. 2 (N=117, 58) 0.0 0.0
Grade 3 Inj.-site Swelling; Post-inj. 2 (N=117,58) 0.0 0.0
Injection-site Pain; Post-inj. 3 (N=115, 57) 2.6 0.0
Grade 3 Inj.-site Pain; Post-inj. 3 (N=115, 57) 0.0 0.0
Injection-site Erythema; Post-inj. 3 (N=115, 57) 0.0 0.0
Grade 3 Inj.-site Erythema; Post-inj 3 (N=115,57) 0.0 0.0
Injection-site Swelling; Post-inj. 3 (N=115, 57) 0.0 0.0
Grade 3 Inj.-site Swelling; Post-inj. 3 (N=115,57) 0.0 0.0
Fever; Post-Any inj. (N=126, 61) 5.6 1.6
Grade 3 Fever; Post-Any inj. (N=126, 61) 0.8 0.0
Headache; Post Any\-inj. (N=126, 61) 7.9 4.9
Grade 3 Headache; Post-Any inj. (N=126, 61) 1.6 1.6
Malaise; Post-Any inj. (N=126, 61) 8.7 4.9
Grade 3 Malaise; Post-Any inj. (N=126, 61) 0.8 0.0
Myalgia; Post Any inj. (N=126, 61) 9.5 4.9
Grade 3 Myalgia; Post-Any inj. (N=126, 61) 0.0 1.6
Asthenia; Post-Any inj. (N=126, 61) 11.1 4.9
Grade 3 Asthenia; Post-Any inj. (N=126, 61) 0.8 0.0
Fever; Post-inj. 1 (N=125, 60) 4.8 0.0
Grade 3 Fever; Post-inj. 1 (N=125, 60) 0.8 0.0
Headache; Post-inj. 1 (N=126, 61) 5.6 4.9
Grade 3 Headache; Post-inj. 1 (N=126, 61) 1.6 1.6
Malaise; Post-inj. 1 (N=126, 61) 7.1 4.9
Grade 3 Malaise; Post-inj. 1 (N=126, 61) 0.0 0.0
Myalgia; Post-inj. 1 (N=126, 61) 7.9 4.9
Grade 3 Myalgia; Post inj. 1 (N=126, 61) 0 1.6
Asthenia; Post-inj. 1 (N=126, 61) 9.5 4.9
Grade 3 Asthenia; Post inj. 1 (N=126, 61) 0.0 0.0
Fever; Post-inj. 2 (N=117, 58) 0.9 1.7
Grade 3 Fever; Post-inj. 2 (N=117, 58) 0.0 0.0
Headache; Post-inj. 2 (N=117, 58) 1.7 0.0
Grade 3 Headache; Post-inj. 2 (N=117, 58) 0.0 0.0
Malaise; Post-inj. 2 (N=117, 58) 0.9 0.0
Grade 3 Malaise; Post-inj. 2 (N=117, 58) 0.9 0.0
Myalgia; Post-inj. 2 (N=117, 58) 1.7 0.0
Grade 3 Myalgia; Post-inj. 2 (N=117, 58) 0.0 0.0
Asthenia; Post-inj. 2 (N=117, 58) 2.6 0.0
Grade 3 Asthenia; Post-inj. 2 (N=117, 58) 0.9 0.0
Fever; Post-inj. 3 (N=113, 57) 0.0 0.0
Grade 3 Fever; Post inj. 3 (N=113, 57) 0.0 0.0
Headache; Post-inj. 3 (N=115, 57) 0.9 0.0
Grade 3 Headache; Post-inj. 3 (N=115, 57) 0.0 0.0
Malaise; Post-inj. 3 (N=115, 57) 0.9 0.0
Grade 3 Malaise; Post-inj. 3 (N=115, 57) 0.0 0.0
Myalgia; Post-inj. 3 (N=115, 57) 0.0 0.0
Grade 3 Myalgia; Post-inj. 3 (N=115, 57) 0.0 0.0
Asthenia; Post-inj. 3 (N=115, 57) 0.0 0.0
Grade 3 Asthenia; Post-inj. 3 (N=115, 57) 0.0 0.0
6.Secondary Outcome
Title Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Hide Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
Healthy adult participants received 3 vaccinations of placebo vaccine.
Overall Number of Participants Analyzed 113 56
Measure Type: Number
Unit of Measure: Percentage of participants
Serotype 1; Pre-injection 1 (N=113, 56) 92.9 87.5
Serotype 1; Post-injection 1 (N=112, 56) 96.4 89.3
Serotype 1; Post-injection 2 (N=104, 53) 99.0 88.7
Serotype 1; Post-injection 3 (N=102, 52) 100.0 94.2
Serotype 2; Pre-injection 1 (N=113, 56) 92.9 94.6
Serotype 2; Post-injection 1 (N=113, 56) 98.2 94.6
Serotype 2; Post-injection 2 (N=104, 53) 100.0 92.5
Serotype 2; Post-injection 3 (N=102, 52) 100.0 98.1
Serotype 3; Pre-injection 1 (N=113, 56) 94.7 94.6
Serotype 3; Post-injection 1 (N=113, 56) 100.0 96.4
Serotype 3; Post-injection 2 (N=104, 53) 100.0 92.5
Serotype 3; Post-injection 3 (N=102, 52) 100.0 96.2
Serotype 4; Pre-injection 1 (N=113, 56) 85.8 87.5
Serotype 4; Post-injection 1 (N=113, 56) 98.2 91.1
Serotype 4; Post-injection 2 (N=104, 52) 100.0 86.5
Serotype 4; Post-injection 3 (N=102, 52) 100.0 90.4
7.Secondary Outcome
Title Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Hide Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non-immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
Healthy adult participants received 3 vaccinations of placebo vaccine.
Overall Number of Participants Analyzed 13 5
Measure Type: Number
Unit of Measure: Percentage of participants
Serotype 1; Pre-injection 1 (N=13, 5) 0.0 0.0
Serotype 1; Post-injection 1 (N=13, 5) 46.2 20.0
Serotype 1; Post-injection 2 (N=13, 5) 61.5 0.0
Serotype 1; Post-injection 3 (N=13, 5) 76.9 20.0
Serotype 2; Pre-injection 1 (N=13, 5) 0.0 0.0
Serotype 2; Post-injection 1 (N=13, 5) 61.5 20.0
Serotype 2; Post-injection 2 (N=13, 5) 92.3 0.0
Serotype 2; Post injection 3 (N=13, 5) 76.9 20.0
Serotype 3; Pre-injection 1 (N=13, 5) 0.0 0.0
Serotype 3; Post-injection 1 (N=13, 5) 84.6 20.0
Serotype 3; Post-injection 2 (N=13, 5) 84.6 0.0
Serotype 3; Post-injection 3 (N=13, 5) 92.3 20.0
Serotype 4; Pre-injection 1 (N=13, 5) 0.0 0.0
Serotype 4; Post-injection 1 (N=13, 5) 76.9 20.0
Serotype 4; Post-injection 2 (N=13, 5) 92.3 0.0
Serotype 4; Post-injection 3 (N=13, 5) 100.0 20.0
8.Secondary Outcome
Title Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
Hide Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
Healthy adult participants received 3 vaccinations of placebo vaccine.
Overall Number of Participants Analyzed 113 56
Measure Type: Number
Unit of Measure: Percentage of participants
At least 1 serotype; Pre-injection 1 (N=113, 56) 96.5 96.4
At least 1 serotype; Post-injection 1 (N=113, 56) 100.0 96.4
At least 1 serotype; Post-injection 2 (N=104, 53) 100.0 94.3
At least 1 serotype; Post-injection 3 (N=102, 52) 100.0 98.1
At least 2 serotypes; Pre-injection 1 (N=113, 56) 93.8 92.9
At least 2 serotypes; Post-injection 1 (N=113, 56) 100.0 94.6
At least 2 serotypes; Post-injection 2 (N=104, 53) 100.0 90.6
At least 2 serotypes; Post-injection 3 (N=102, 52) 100.0 96.2
At least 3 serotypes; Pre-injection 1 (N=113, 56) 92.0 91.1
At least 3 serotypes; Post-injection 1 (N=113, 56) 96.5 94.6
At least 3 serotypes; Post-injection 2 (N=104, 53) 100.0 88.7
At least 3 serotypes; Post-injection 3 (N=102, 52) 100.0 94.2
All 4 serotypes; Pre-injection 1 (N=113, 56) 84.1 83.9
All 4 serotypes; Post-injection 1 (N=113, 56) 95.6 85.7
All 4 serotypes; Post-injection 2 (N=104, 53) 99.0 84.9
All 4 serotypes; Post-injection 3 (N=102, 52) 100.0 90.4
9.Secondary Outcome
Title Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
Hide Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
Healthy adult participants received 3 vaccinations of placebo vaccine.
Overall Number of Participants Analyzed 13 5
Measure Type: Number
Unit of Measure: Percentage of participants
At least 1 serotype; Pre-injection 1 (N=13, 5) 0.0 0.0
At least 1 serotype; Post-injection 1 (N=13, 5) 92.3 20.0
At least 1 serotype; Post-injection 2 (N=13, 5) 100.0 0.0
At least 1 serotype; Post-injection 3 (N=13, 5) 100.0 20.0
At least 2 serotypes; Pre-injection 1 (N=13, 5) 0.0 0.0
At least 2 serotypes; Post-injection 1 (N=13, 5) 84.6 20.0
At least 2 serotypes; Post-injection 2 (N=13, 5) 84.6 0.0
At least 2 serotypes; Post-injection 3 (N=13, 5) 92.3 20.0
At least 3 serotypes; Pre-injection 1 (N=13, 5) 0.0 0.0
At least 3 serotypes; Post-injection 1 (N=13, 5) 53.8 20.0
At least 3 serotypes; Post-injection 2 (N=13, 5) 84.6 0.0
At least 3 serotypes; Post-injection 3 (N=13, 5) 76.9 20.0
All 4 serotypes; Pre-injection 1 (N=13, 5) 0.0 0.0
All 4 serotypes; Post-injection 1 (N=13, 5) 38.5 20.0
All 4 serotypes; Post-injection 2 (N=13, 5) 61.5 0.0
All 4 serotypes; Post-injection 3 (N=13, 5) 76.9 20.0
10.Secondary Outcome
Title Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Hide Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Healthy adult participants who received 3 vaccinations of the CYD Dengue Vaccine.
Healthy adult participants who received 3 vaccinations of placebo vaccine.
Overall Number of Participants Analyzed 113 56
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilutions)
Serotype 1; Pre-injection 1 (N=113, 56)
279
(199 to 392)
329
(196 to 553)
Serotype 1; Post-injection 1 (N=112, 56)
925
(656 to 1304)
401
(232 to 691)
Serotype 1; Post-injection 2 (N=104, 53)
807
(591 to 1101)
432
(245 to 760)
Serotype 1; Post-injection 3 (N=102, 52)
636
(485 to 834)
362
(235 to 558)
Serotype 2; Pre-injection 1 (N=113, 56)
312
(225 to 432)
344
(221 to 537)
Serotype 2; Post-injection 1 (N=113, 56)
1030
(765 to 1385)
413
(268 to 636)
Serotype 2; Post-injection 2 (N=104, 53)
1010
(792 to 1288)
422
(254 to 702)
Serotype 2; Post-injection 3 (N=102, 52)
624
(493 to 790)
357
(242 to 528)
Serotype 3; Pre-injection 1 (N=113, 56)
338
(249 to 458)
302
(195 to 469)
Serotype 3; Post-injection 1 (N=113, 56)
1324
(1002 to 1749)
405
(263 to 623)
Serotype 3; Post-injection 2 (N=104, 53)
1131
(879 to 1455)
361
(219 to 594)
Serotype 3; Post-injection 3 (N=102, 52)
912
(726 to 1145)
368
(248 to 547)
Serotype 4; Pre-injection 1 (N=113, 56)
73.1
(55.1 to 96.9)
77.6
(53.6 to 112)
Serotype 4; Post-injection 1 (N=113, 56)
424
(325 to 554)
99.1
(67.8 to 145)
Serotype 4; Post-injection 2 (N=104, 52)
346
(287 to 417)
94.2
(61.6 to 144)
Serotype 4; Post-injection 3 (N=102, 52)
387
(309 to 485)
117
(79.7 to 172)
11.Secondary Outcome
Title Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Hide Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers ratios were assessed in the Full Analysis Set with available data for each time point.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Healthy adult participants who received 3 vaccinations of the CYD Dengue Vaccine.
Healthy adult participants who received 3 vaccinations of placebo vaccine.
Overall Number of Participants Analyzed 113 56
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer ratio
Serotype 1; Post-inj. 1/Pre-inj. 1 (N=112,56)
3.24
(2.47 to 4.25)
1.22
(0.994 to 1.49)
Serotype 1; Post-inj. 2/Pre-inj. 1 (N=104,53)
2.93
(2.28 to 3.77)
1.29
(1.01 to 1.65)
Serotype 1; Post-inj. 3/Pre-inj. 1 (N=102,52)
2.31
(1.82 to 2.94)
1.10
(0.786 to 1.55)
Serotype 2; Post-inj. 1/Pre-inj. 1 (N=113,56)
3.30
(2.59 to 4.20)
1.20
(1.01 to 1.43)
Serotype 2; Post-inj. 2/Pre-inj. 1 (N=104,53)
3.09
(2.34 to 4.08)
1.19
(0.946 to 1.50)
Serotype 2; Post-inj. 3/Pre-inj. 1 (N=102,52)
1.91
(1.49 to 2.45)
1.00
(0.746 to 1.35)
Serotype 3; Post-inj. 1/Pre-inj. 1 (N=113,56)
3.92
(3.00 to 5.13)
1.34
(1.07 to 1.69)
Serotype 3; Post-inj. 2/Pre-inj. 1 (N=104,53)
3.32
(2.50 to 4.41)
1.15
(0.878 to 1.50)
Serotype 3; Post-inj. 3/Pre-inj. 1 (N=102,52)
2.71
(2.10 to 3.49)
1.17
(0.820 to 1.67)
Serotype 4; Post-inj. 1/Pre-inj. 1 (N=113,56)
5.80
(4.23 to 7.96)
1.28
(0.988 to 1.65)
Serotype 4; Post-inj. 2/Pre-inj. 1 (N=104,52)
4.86
(3.48 to 5.99)
1.17
(0.912 to 1.50)
Serotype 4; Post-inj. 3/Pre-inj. 1 (N=102,52)
5.18
(4.03 to 6.66)
1.43
(1.06 to 1.93)
12.Secondary Outcome
Title Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Hide Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
Healthy adult participants received 3 vaccinations of placebo vaccine.
Overall Number of Participants Analyzed 13 5
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilutions)
Serotype 1; Pre-injection 1 (N=13, 5)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Serotype 1; Post-injection 1 (N=13, 5)
15.5
(5.83 to 41.3)
7.01
(2.75 to 17.9)
Serotype 1; Post-injection 2 (N=13, 5)
28.2
(9.88 to 80.4)
5.00
(5.00 to 5.00)
Serotype 1; Post-injection 3 (N=13, 5)
37.1
(16.0 to 86.5)
11.8
(1.09 to 126)
Serotype 2; Pre-injection 1 (N=13, 5)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Serotype 2; Post-injection 1 (N=13, 5)
32.1
(9.14 to 112)
8.27
(2.04 to 33.5)
Serotype 2; Post-injection 2 (N=13, 5)
107
(27.9 to 410)
5.00
(5.00 to 5.00)
Serotype 2; Post-injection 3 (N=13, 5)
66.8
(22.8 to 196)
8.93
(1.78 to 44.7)
Serotype 3; Pre-injection 1 (N=13, 5)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Serotype 3; Post-injection 1 (N=13, 5)
53.8
(17.7 to 163)
5.96
(3.66 to 9.69)
Serotype 3; Post-injection 2 (N=13, 5)
83.1
(30.3 to 228)
5.00
(5.00 to 5.00)
Serotype 3; Post-injection 3 (N=13, 5)
98.6
(48.1 to 202)
9.72
(1.53 to 61.6)
Serotype 4; Pre-injection 1 (N=13, 5)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Serotype 4; Post-injection 1 (N=13, 5)
81.8
(25.0 to 267)
5.96
(3.66 to 9.69)
Serotype 4; Post-injection 2 (N=13, 5)
68.4
(33.3 to 141)
5.00
(5.00 to 5.00)
Serotype 4; Post-injection 3 (N=13, 5)
111
(79.9 to 155)
7.29
(2.56 to 20.8)
13.Secondary Outcome
Title Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Hide Description Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Time Frame Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers ratios were assessed in the Full Analysis Set with available data for each time point.
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description:
Healthy adult participants who received 3 vaccinations of the CYD Dengue Vaccine.
Healthy adult participants who received 3 vaccinations of placebo vaccine.
Overall Number of Participants Analyzed 13 5
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer ratio
Serotype 1; Post-inj. 1/Pre-inj. 1 (N=13,5)
3.10
(1.17 to 8.25)
1.40
(0.549 to 3.57)
Serotype 1; Post-inj. 2/Pre-inj. 1 (N=13,5)
5.64
(1.98 to 16.1)
1.00
(1.00 to 1.00)
Serotype 1; Post-inj. 3/Pre-inj. 1 (N=13,5)
7.43
(3.19 to 17.3)
2.35
(0.219 to 25.3)
Serotype 2; Post-inj. 1/Pre-inj. 1 (N=13,5)
6.41
(1.83 to 22.5)
1.65
(0.409 to 6.70)
Serotype 2; Post-inj. 2/Pre-inj. 1 (N=13,5)
21.4
(5.59 to 81.9)
1.00
(1.00 to 1.00)
Serotype 2; Post-inj. 3/Pre-inj. 1 (N=13,5)
13.4
(4.56 to 39.1)
1.79
(0.357 to 8.95)
Serotype 3; Post-inj. 1/Pre-inj. 1 (N=13,5)
10.8
(3.55 to 32.6)
1.58
(0.441 to 5.69)
Serotype 3; Post-inj. 2/Pre-inj. 1 (N=13,5)
16.6
(6.06 to 45.5)
1.00
(1.00 to 1.00)
Serotype 3; Post-inj. 3/Pre-inj. 1 (N=13,5)
19.7
(9.63 to 40.4)
1.94
(0.307 to 12.3)
Serotype 4; Post-inj. 1/Pre-inj. 1 (N=13,5)
16.4
(5.01 to 53.4)
1.19
(0.733 to 1.94)
Serotype 4; Post-inj. 2/Pre-inj. 1 (N=13,5)
13.7
(6.66 to 28.1)
1.00
(1.00 to 1.00)
Serotype 4; Post-inj. 3/Pre-inj. 1 (N=13,5)
22.2
(16.0 to 31.0)
1.46
(0.511 to 4.16)
Time Frame Adverse event data were collected from Day 0 up to 1 year post injection 1.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CYD Dengue Vaccine Group Placebo Group
Hide Arm/Group Description Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. Healthy adult participants received 3 vaccinations of placebo vaccine.
All-Cause Mortality
CYD Dengue Vaccine Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
CYD Dengue Vaccine Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/127 (0.79%)      1/61 (1.64%)    
Blood and lymphatic system disorders     
Anaemia megaloblastic * 1  1/127 (0.79%)  1 0/61 (0.00%)  0
General disorders     
Pyrexia * 1  1/127 (0.79%)  1 0/61 (0.00%)  0
Infections and infestations     
Viral upper respiratory tract infection * 1  0/127 (0.00%)  0 1/61 (1.64%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
CYD Dengue Vaccine Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/127 (11.02%)      3/61 (4.92%)    
General disorders     
Injection site Pain † 1  12/127 (9.45%)  12 3/61 (4.92%)  3
Fever † 1  7/126 (5.56%)  7 1/61 (1.64%)  1
Malaise † 1  11/126 (8.73%)  11 3/61 (4.92%)  3
Asthenia † 1  14/126 (11.11%)  14 3/61 (4.92%)  3
Musculoskeletal and connective tissue disorders     
Myalgia † 1  12/126 (9.52%)  12 3/61 (4.92%)  3
Nervous system disorders     
Headache † 1  10/126 (7.94%)  10 3/61 (4.92%)  3
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
[Not Specified]
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: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Publications of Results:
Dubey AP, Agarkhedkar S, Chhatwal J, Narayan A, Ganguly S, Wartel TA, Bouckenooghe A, Menezes J. Immunogenicity and safety of a tetravalent dengue vaccine in healthy adults in India: A randomized, observer-blind, placebo-controlled phase II trial. Hum Vaccin Immunother. 2016;12(2):512-8. doi: 10.1080/21645515.2015.1076598.
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01550289    
Other Study ID Numbers: CYD47
UTN: U1111-1114-7909 ( Other Identifier: WHO )
First Submitted: March 7, 2012
First Posted: March 9, 2012
Results First Submitted: September 14, 2016
Results First Posted: November 3, 2016
Last Update Posted: December 28, 2016