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Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America

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ClinicalTrials.gov Identifier: NCT00993447
Recruitment Status : Completed
First Posted : October 12, 2009
Results First Posted : November 29, 2016
Last Update Posted : November 29, 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 Hemorrhagic Fever
Dengue Virus
Dengue Fever
Interventions Biological: CYD Dengue Vaccine
Biological: Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis
Enrollment 600
Recruitment Details Study participants were enrolled from 09 October 2009 to 25 February 2010 in 3 clinic centers in Colombia, 1 in Honduras, 3 in Mexico, and 1 in Puerto Rico.
Pre-assignment Details A total of 600 participants who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.
Arm/Group Title Dengue Vaccine Group Control Group
Hide Arm/Group Description Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
Period Title: Overall Study
Started 401 199
Completed 364 180
Not Completed 37 19
Reason Not Completed
Withdrawal by Subject             23             8
Protocol Violation             12             8
Lost to Follow-up             1             3
Adverse Event             1             0
Arm/Group Title Dengue Vaccine Group Control Group Total
Hide Arm/Group Description Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection. Total of all reporting groups
Overall Number of Baseline Participants 401 199 600
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 401 participants 199 participants 600 participants
<=18 years
401
 100.0%
199
 100.0%
600
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 401 participants 199 participants 600 participants
12.6  (2.1) 12.5  (2.1) 12.55  (2.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 401 participants 199 participants 600 participants
Female
204
  50.9%
108
  54.3%
312
  52.0%
Male
197
  49.1%
91
  45.7%
288
  48.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 401 participants 199 participants 600 participants
Colombia 105 54 159
Honduras 106 52 158
Mexico 119 58 177
Puerto Rico 71 35 106
1.Primary Outcome
Title Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Hide Description Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).
Time Frame Day 0 (pre-each vaccination) and Day 28 post-each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers against each dengue virus serotype strain were assessed in the Per Protocol Analysis Set.
Arm/Group Title Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
Overall Number of Participants Analyzed 401 199
Measure Type: Number
Unit of Measure: Percentage of participants
Serotype 1; Pre-inj. 1 (N=379,191) 64.9 68.1
Serotype 1; Post-inj. 1 (N=379,191) 73.1 67.0
Serotype 1; Pre-inj. 2 (N=353,174) 75.6 67.8
Serotype 1; Post-inj. 2 (N=353,174) 85.0 69.0
Serotype 1; Pre-inj. 3 (N=335,163) 79.7 73.6
Serotype 1; Post-inj. 3 (N=335,163) 94.6 75.5
Serotype 2; Pre-inj. 1 (N=379,191) 69.9 74.3
Serotype 2; Post-inj. 1 (N=379,191) 85.2 72.8
Serotype 2; Pre-inj. 2 (N=353,174) 87.3 71.8
Serotype 2; Post-inj. 2 (N=353,174) 96.9 73.0
Serotype 2; Pre-inj. 3 (N=335,163) 91.9 76.7
Serotype 2; Post-inj. 3 (N=335,163) 99.1 78.5
Serotype 3; Pre-inj. 1 (N=379,191) 69.9 73.3
Serotype 3; Post-inj. 1 (N=379,191) 90.8 74.3
Serotype 3; Pre-inj. 2 (N=353,174) 90.9 72.4
Serotype 3; Post-inj. 2 (N=353,174) 98.6 73.6
Serotype 3; Pre-inj. 3 (N=335,163) 96.4 74.8
Serotype 3; Post-inj. 3 (N=335,163) 100.0 76.7
Serotype 4; Pre-inj. 1 (N=379,191) 63.1 68.1
Serotype 4; Post-inj. 1 (N=379,191) 92.6 62.3
Serotype 4; Pre-inj. 2 (N=353,174) 92.4 66.7
Serotype 4; Post-inj. 2 (N=353,174) 96.6 70.1
Serotype 4; Pre-inj. 3 (N=335,163) 95.8 69.9
Serotype 4; Post-inj. 3 (N=335,163) 98.8 69.3
2.Primary Outcome
Title Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Hide Description Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (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 Yellow Fever titer.
Time Frame Day 0 (pre-each vaccination) and Day 28 post-each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
Arm/Group Title Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
Overall Number of Participants Analyzed 316 160
Measure Type: Number
Unit of Measure: Percentage of Participants
Serotype 1; Pre-inj. 1 (N=316,160) 81.3 84.4
Serotype 1; Post-inj. 1 (N=305,158) 90.8 82.3
Serotype 1; Pre-inj. 2 (N=295,148) 90.5 82.4
Serotype 1; Post-inj. 2 (N=293,147) 95.6 84.4
Serotype 1; Pre-inj. 3 (N=288,143) 92.0 87.4
Serotype 1; Post-inj. 3 (N=287,143) 97.6 88.8
Serotype 2; Pre-inj. 1 (N=316,160) 88.0 91.9
Serotype 2; Post-inj. 1 (N=305,158) 96.4 89.9
Serotype 2; Pre-inj. 2 (N=295,148) 96.6 89.2
Serotype 2; Post-inj. 2 (N=293,147) 98.6 90.5
Serotype 2; Pre-inj. 3 (N=288,143) 96.5 90.9
Serotype 2; Post-inj. 3 (N=287,143) 99.7 92.3
Serotype 3; Pre-inj. 1 (N=316,160) 88.3 90.6
Serotype 3; Post-inj. 1 (N=305,158) 96.7 89.9
Serotype 3; Pre-inj. 2 (N=295,148) 96.6 87.8
Serotype 3; Post-inj. 2 (N=293,147) 99.0 88.4
Serotype 3; Pre-inj. 3 (N=288,143) 97.9 89.5
Serotype 3; Post-inj. 3 (N=287,143) 100.0 89.5
Serotype 4; Pre-inj. 1 (N=316,160) 79.4 84.4
Serotype 4; Post-inj. 1 (N=305,158) 97.4 76.6
Serotype 4; Pre-inj. 2 (N=295,148) 96.9 81.1
Serotype 4; Post-inj. 2 (N=293,147) 98.0 84.4
Serotype 4; Pre-inj. 3 (N=288,143) 99.3 84.6
Serotype 4; Post-inj. 3 (N=287,143) 100.0 84.6
3.Primary Outcome
Title Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Hide Description Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) naïve participants are defined as those participants with < 10 1/dil for all serotypes with parental dengue virus strains and for Yellow Fever titer.
Time Frame Day 0 (pre-each vaccination) and Day 28 post-each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
Arm/Group Title Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
Overall Number of Participants Analyzed 85 38
Measure Type: Number
Unit of Measure: Percentage of participants
Serotype 1; Pre-inj. 1 (N=85,38) 0.0 0.0
Serotype 1; Post-inj. 1 (N=84,37) 7.1 2.7
Serotype 1; Pre-inj. 2 (N=78,36) 17.9 5.6
Serotype 1; Post-inj. 2 (N=78,36) 44.9 5.6
Serotype 1; Pre-inj. 3 (N=77,36) 33.8 16.7
Serotype 1; Post-inj. 3 (N=77,36) 81.8 19.4
Serotype 2; Pre-inj. 1 (N=85,38) 0.0 0.0
Serotype 2; Post-inj. 1 (N=84,37) 42.9 0.0
Serotype 2; Pre-inj. 2 (N=78,36) 51.3 2.8
Serotype 2; Post-inj. 2 (N=78,36) 89.7 5.6
Serotype 2; Pre-inj. 3 (N=77,36) 70.1 16.7
Serotype 2; Post-inj. 3 (N=77,36) 96.1 19.4
Serotype 3; Pre-inj. 1 (N=85,38) 0.0 0.0
Serotype 3; Post-inj. 1 (N=84,37) 67.9 10.8
Serotype 3; Pre-inj. 2 (N=78,36) 66.7 8.3
Serotype 3; Post-inj. 2 (N=78,36) 94.9 8.3
Serotype 3; Pre-inj. 3 (N=77,36) 89.6 5.6
Serotype 3; Post-inj. 3 (N=77,36) 100.0 16.7
Serotype 4; Pre-inj. 1 (N=85,38) 0.0 0.0
Serotype 4; Post-inj. 1 (N=84,37) 73.8 2.7
Serotype 4; Pre-inj. 2 (N=78,36) 73.1 5.6
Serotype 4; Post-inj. 2 (N=78,36) 91.0 8.3
Serotype 4; Pre-inj. 3 (N=77,36) 80.5 8.3
Serotype 4; Post-inj. 3 (N=77,36) 94.8 5.6
4.Primary Outcome
Title Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
Hide Description Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).
Time Frame Day 0 (before each vaccination) and Day 28 post each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.
Arm/Group Title Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
Overall Number of Participants Analyzed 401 199
Measure Type: Number
Unit of Measure: Percentage of participants
At Least 1 Serotype; Pre-inj 1; 1 (N=401,199) 75.1 77.9
At Least 1 Serotype; Post-inj. 1 (N=389,196) 98.2 78.6
At Least 1 Serotype; Pre-inj. 2 (N=373,185) 99.2 76.2
At Least 1 Serotype; Post-inj. 2 (N=371,184) 99.7 76.6
At Least 1 Serotype; Pre-inj. 3 (N=365,180) 100.0 79.4
At Least 1 Serotype; Post-inj. 3 (N=364,180) 100.0 78.9
At Least 2 Serotypes; Pre-inj. 1 (N=401,199) 69.1 72.9
At Least 2 Serotypes; Post-inj. 1 (N=389,196) 91.0 70.9
At Least 2 Serotypes; Pre-inj. 2 (N=373,185) 91.4 71.9
At Least 2 Serotypes; Post-inj. 2 (N=371,184) 98.9 71.2
At Least 2 Serotypes; Pre-inj. 3 (N=365,180) 96.2 75.6
At Least 2 Serotypes; Post-inj. 3 (N=364,180) 100.0 76.7
At Least 3 Serotypes; Pre-inj. 1 (N=401,199) 64.6 69.8
At Least 3 Serotypes; Post-inj. 1 (N=381,196) 79.9 67.3
At Least 3 Serotypes; Pre-inj. 2 (N=373,185) 81.8 68.1
At Least 3 Serotypes; Post-inj. 2 (N=371,184) 94.3 69.0
At Least 3 Serotypes; Pre-inj. 3 (N=365,180) 88.2 70.6
At Least 3 Serotypes; Post-inj. 3 (N=364,180) 98.6 72.2
All 4 Serotypes; Pre-inj. 1 (N=401,199) 56.9 61.8
All 4 Serotypes; Post-inj. 1 (N=389,196) 71.2 59.2
All 4 Serotypes; Pre-inj. 2 (N=373,185) 72.4 60.5
All 4 Serotypes; Post-inj. 2 (N=371,184) 83.3 66.3
All 4 Serotypes; Pre-inj. 3 (N=365,180) 77.8 64.4
All 4 Serotypes; Post-inj. 3 (N=364,180) 93.4 66.7
5.Primary Outcome
Title Percentage of Flavi Virus-Immune Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
Hide Description Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).
Time Frame Day 0 (before each vaccination) and Day 28 post each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.
Arm/Group Title Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
Overall Number of Participants Analyzed 316 160
Measure Type: Number
Unit of Measure: Percentage of participants
At Least 1 Serotype; Pre-inj 1; 1 (N=401,199) 95.3 96.9
At Least 1 Serotype; Post-inj. 1 (N=389,196) 99.0 93.7
At Least 1 Serotype; Pre-inj. 2 (N=373,185) 99.7 91.9
At Least 1 Serotype; Post-inj. 2 (N=371,184) 99.7 93.2
At Least 1 Serotype; Pre-inj. 3 (N=365,180) 100.0 93.7
At Least 1 Serotype; Post-inj. 3 (N=364,180) 100.0 93.0
At Least 2 Serotypes; Pre-inj. 1 (N=401,199) 87.7 90.6
At Least 2 Serotypes; Post-inj. 1 (N=389,196) 97.4 88.0
At Least 2 Serotypes; Pre-inj. 2 (N=373,185) 97.3 89.2
At Least 2 Serotypes; Post-inj. 2 (N=371,184) 99.0 87.8
At Least 2 Serotypes; Pre-inj. 3 (N=365,180) 98.6 91.6
At Least 2 Serotypes; Post-inj. 3 (N=364,180) 100.0 92.3
At Least 3 Serotypes; Pre-inj. 1 (N=401,199) 92.0 86.9
At Least 3 Serotypes; Post-inj. 1 (N=381,196) 95.1 83.5
At Least 3 Serotypes; Pre-inj. 2 (N=373,185) 94.2 84.5
At Least 3 Serotypes; Post-inj. 2 (N=371,184) 98.3 85.0
At Least 3 Serotypes; Pre-inj. 3 (N=365,180) 96.2 86.7
At Least 3 Serotypes; Post-inj. 3 (N=364,180) 99.7 87.4
All 4 Serotypes; Pre-inj. 1 (N=401,199) 72.2 76.9
All 4 Serotypes; Post-inj. 1 (N=389,196) 89.8 73.4
All 4 Serotypes; Pre-inj. 2 (N=373,185) 89.5 75.0
All 4 Serotypes; Post-inj. 2 (N=371,184) 94.2 81.6
All 4 Serotypes; Pre-inj. 3 (N=365,180) 91.0 80.4
All 4 Serotypes; Post-inj. 3 (N=364,180) 97.6 82.5
6.Primary Outcome
Title Percentage of Flavi Virus-Naive Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Pre and Post-Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine
Hide Description Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).
Time Frame Day 0 (before each vaccination) and Day 28 post each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers against each dengue virus serotype strain were assessed in the Per Full Analysis Set.
Arm/Group Title Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
Overall Number of Participants Analyzed 85 38
Measure Type: Number
Unit of Measure: Percentage of participants
At Least 1 Serotype; Pre-inj 1; 1 (N=401,199) 0.0 0.0
At Least 1 Serotype; Post-inj. 1 (N=389,196) 95.0 16.2
At Least 1 Serotype; Pre-inj. 2 (N=373,185) 97.4 13.9
At Least 1 Serotype; Post-inj. 2 (N=371,184) 100.0 11.1
At Least 1 Serotype; Pre-inj. 3 (N=365,180) 100.0 22.2
At Least 1 Serotype; Post-inj. 3 (N=364,180) 100.0 25.0
At Least 2 Serotypes; Pre-inj. 1 (N=401,199) 0.0 0.0
At Least 2 Serotypes; Post-inj. 1 (N=389,196) 67.9 0.0
At Least 2 Serotypes; Pre-inj. 2 (N=373,185) 69.2 2.8
At Least 2 Serotypes; Post-inj. 2 (N=371,184) 98.7 5.6
At Least 2 Serotypes; Pre-inj. 3 (N=365,180) 87.0 13.9
At Least 2 Serotypes; Post-inj. 3 (N=364,180) 100.0 16.7
At Least 3 Serotypes; Pre-inj. 1 (N=401,199) 0.0 0.0
At Least 3 Serotypes; Post-inj. 1 (N=381,196) 25.0 0.0
At Least 3 Serotypes; Pre-inj. 2 (N=373,185) 34.6 2.8
At Least 3 Serotypes; Post-inj. 2 (N=371,184) 79.5 5.6
At Least 3 Serotypes; Pre-inj. 3 (N=365,180) 58.4 8.3
At Least 3 Serotypes; Post-inj. 3 (N=364,180) 94.8 13.9
All 4 Serotypes; Pre-inj. 1 (N=401,199) 0.0 0.0
All 4 Serotypes; Post-inj. 1 (N=389,196) 3.6 0.0
All 4 Serotypes; Pre-inj. 2 (N=373,185) 7.7 2.8
All 4 Serotypes; Post-inj. 2 (N=371,184) 42.3 5.6
All 4 Serotypes; Pre-inj. 3 (N=365,180) 28.6 2.8
All 4 Serotypes; Post-inj. 3 (N=364,180) 77.9 5.6
7.Primary Outcome
Title Summary of Geometric Mean Titers (GMTs) of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Hide Description Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).
Time Frame Day 0 (before each vaccination) and Day 28 post-each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
Arm/Group Title Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
Overall Number of Participants Analyzed 401 199
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Serotype 1; Pre-inj. 1 (N=401,199)
74.2
(58.8 to 93.6)
81.9
(59.2 to 113)
Serotype 1; Post-inj. 1 (N=389,196)
221
(167 to 292)
77.1
(55.8 to 106)
Serotype 1; Pre-inj. 2 (N=373,185)
193
(149 to 251)
96.6
(67.1 to 139)
Serotype 1; Post-inj. 2 (N=371,184)
276
(215 to 355)
102
(70.9 to 147)
Serotype 1; Pre-inj. 3 (N=365,180)
204
(159 to 262)
113
(80.0 to 159)
Serotype 1; Post-inj. 3 (N=364,180)
320
(258 to 396)
106
(75.4 to 149)
Serotype 2; Pre-inj. 1 (N=401,199)
92.6
(73.9 to 116)
100
(73.5 to 136)
Serotype 2; Post-inj. 1 (N=389,196)
409
(320 to 524)
90.4
(66.6 to 123)
Serotype 2; Pre-inj. 2 (N=373,185)
326
(260 to 408)
117
(82.2 to 166)
Serotype 2; Post-inj. 2 (N=371,184)
504
(414 to 613)
114
(80.8 to 160)
Serotype 2; Pre-inj. 3 (N=365,180)
300
(245 to 368)
133
(95.6 to 186)
Serotype 2; Post-inj. 3 (N=364,180)
486
(414 to 572)
133
(96.2 to 185)
Serotype 3; Pre-inj. 1 (N=401,199)
85.0
(68.1 to 106)
88.8
(65.9 to 120)
Serotype 3; Post-inj. 1 (N=389,196)
442
(352 to 554)
93.2
(69.1 to 126)
Serotype 3; Pre-inj. 2 (N=372,185)
301
(243 to 372)
107
(77.0 to 149)
Serotype 3; Post-inj. 2 (N=371,184)
502
(421 to 599)
108
(76.8 to 151)
Serotype 3; Pre-inj. 3 (N=365,180)
379
(313 to 458)
123
(87.3 to 172)
Serotype 3; Post-inj. 3 (N=364,180)
594
(511 to 692)
121
(86.6 to 168)
Serotype 4; Pre-inj. 1 (N=401,199)
37.2
(31.1 to 44.5)
40.1
(31.2 to 51.5)
Serotype 4; Post-inj. 1 (N=389,196)
416
(347 to 498)
34.1
(26.5 to 43.9)
Serotype 4; Pre-inj. 2 (N=373,185)
200
(171 to 233)
43.8
(33.2 to 57.8)
Serotype 4; Post-inj. 2 (N=369,184)
305
(265 to 352)
43.9
(33.5 to 57.5)
Serotype 4; Pre-inj. 3 (N=365,180)
182
(158 to 210)
47.7
(36.4 to 62.6)
Serotype 4; Post-inj. 3 (N=364,180)
273
(241 to 309)
42.8
(33.0 to 55.5)
8.Primary Outcome
Title Summary of Geometric Mean Titers Ratios of Antibodies Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Hide Description Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Geometric mean titer ratio is the geometric mean of individual post vaccination/pre vaccination titer of antibodies to each parental dengue virus serotype strain.
Time Frame Day 0 (before each vaccination) and Day 28 post each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
Arm/Group Title Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
Overall Number of Participants Analyzed 401 199
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serotype 1; Post-inj. 1/Pre-inj. 1 (N=389,196)
2.36
(2.02 to 2.76)
0.756
(0.689 to 0.829)
Serotype 1; Post-inj. 2/Pre-inj. 1 (N=371,184)
2.74
(2.33 to 3.21)
1.02
(0.820 to 1.27)
Serotype 1; Post-inj. 2/Pre-inj. 2 (N=371,184)
1.19
(1.06 to 1.34)
0.851
(0.735 to 0.985)
Serotype 1; Post-inj. 3/Pre-inj. 1 (N=364,180)
3.16
(2.73 to 3.66)
1.03
(0.834 to 1.27)
Serotype 1; Post-inj. 3/Pre-inj. 2 (N=364,180)
1.38
(1.22 to 1.56)
0.859
(0.710 to 1.04)
Serotype 1; Post-inj. 3/Pre-inj. 3 (N=364,180)
1.35
(1.25 to 1.46)
0.777
(0.699 to 0.862)
Serotype 2; Post-inj. 1/Pre-inj. 1 (N=389,196)
3.55
(3.04 to 4.15)
0.760
(0.702 to 0.823)
Serotype 2; Post-inj. 2/Pre-inj. 1 (N=371,184)
4.09
(3.49 to 4.80)
0.983
(0.805 to 1.20)
Serotype 2; Post-inj. 2/Pre-inj. 2 (N=371,184)
1.40
(1.25 to 1.58)
0.811
(0.698 to 0.941)
Serotype 2; Post-inj. 3/Pre-inj. 1 (N=364,180)
3.97
(3.39 to 4.64)
1.16
(0.955 to 1.41)
Serotype 2; Post-inj. 3/Pre-inj. 2 (N=364,180)
1.36
(1.19 to 1.55)
0.957
(0.777 to 1.18)
Serotype 2; Post-inj. 3/Pre-inj. 3 (N=364,180)
1.51
(1.38 to 1.64)
0.844
(0.770 to 0.926)
Serotype 3; Post-inj. 1/Pre-inj. 1 (N=389,196)
4.24
(3.61 to 4.98)
0.864
(0.786 to 0.950)
Serotype 3; Post-inj. 2/Pre-inj. 1 (N=371,184)
4.52
(3.88 to 5.26)
1.04
(0.852 to 1.28)
Serotype 3; Post-inj. 2/Pre-inj. 2 (N=370,184)
1.57
(1.40 to 1.76)
0.840
(0.725 to 0.975)
Serotype 3; Post-inj. 3/Pre-inj. 1 (N=364,180)
5.27
(4.55 to 6.10)
1.15
(0.960 to 1.39)
Serotype 3; Post-inj. 3/Pre-inj. 2 (N=363,180)
1.86
(1.64 to 2.10)
0.937
(0.780 to 1.13)
Serotype 3; Post-inj. 3/Pre-inj. 3 (N=364,180)
1.52
(1.41 to 1.63)
0.815
(0.743 to 0.895)
Serotype 4; Post-inj. 1/Pre-inj. 1 (N=389,196)
8.63
(7.09 to 10.5)
0.672
(0.603 to 0.750)
Serotype 4; Post-inj. 2/Pre-inj. 1 (N=369,184)
6.14
(5.22 to 7.21)
0.887
(0.725 to 1.09)
Serotype 4; Post-inj. 2/Pre-inj. 2 (N=369,184)
1.45
(1.29 to 1.62)
0.800
(0.703 to 0.911)
Serotype 4; Post-inj. 3/Pre-inj. 1 (N=364,180)
5.47
(4.72 to 6.34)
0.871
(0.720 to 1.05)
Serotype 4; Post-inj. 3/Pre-inj. 2 (N=364,180)
1.30
(1.16 to 1.46)
0.771
(0.656 to 0.906)
Serotype 4; Post-inj. 3/Pre-inj. 3 (N=364,180)
1.45
(1.34 to 1.56)
0.723
(0.671 to 0.780)
9.Primary Outcome
Title Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Hide Description Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-immune subjects at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.
Time Frame Day 0 (before each vaccination) and Day 28 post each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
Arm/Group Title Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
Overall Number of Participants Analyzed 316 160
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Serotype 1; Pre-inj. 1 (N=316,160)
153
(121 to 194)
162
(117 to 224)
Serotype 1; Post-inj. 1 (N=305,158)
604
(468 to 780)
148
(107 to 205)
Serotype 1; Pre-inj. 2 (N=295,148)
447
(352 to 567)
192
(133 to 279)
Serotype 1; Post-inj. 2 (N=293,147)
607
(483 to 764)
199
(138 to 287)
Serotype 1; Pre-inj. 3 (N=288,143)
435
(344 to 550)
225
(161 to 315)
Serotype 1; Post-inj. 3 (N=287,143)
580
(471 to 715)
205
(146 to 287)
Serotype 2; Pre-inj. 1 (N=316,160)
203
(164 to 252)
207
(156 to 275)
Serotype 2; Post-inj. 1 (N=305,158)
1001
(811 to 1236)
181
(136 to 242)
Serotype 2; Pre-inj. 2 (N=295,148)
673
(555 to 817)
251
(179 to 351)
Serotype 2; Post-inj. 2 (N=293,147)
888
(738 to 1067)
232
(167 to 321)
Serotype 2; Pre-inj. 3 (N=288,143)
554
(461 to 667)
265
(195 to 361)
Serotype 2; Post-inj. 3 (N=287,143)
741
(631 to 869)
266
(196 to 359)
Serotype 3; Pre-inj. 1 (N=316,160)
182
(147 to 225)
179
(136 to 237)
Serotype 3; Post-inj. 1 (N=305,158)
863
(700 to 1064)
180
(135 to 239)
Serotype 3; Pre-inj. 2 (N=295,148)
556
(456 to 679)
221
(161 to 304)
Serotype 3; Post-inj. 2 (N=293,147)
782
(654 to 936)
215
(155 to 297)
Serotype 3; Pre-inj. 3 (N=288,143)
615
(510 to 743)
265
(193 to 362)
Serotype 3; Post-inj. 3 (N=287,143)
827
(704 to 972)
248
(181 to 340)
Serotype 4; Pre-inj. 1 (N=316,160)
63.8
(52.9 to 76.9)
66.5
(51.4 to 86.1)
Serotype 4; Post-inj. 1 (N=305,158)
549
(465 to 649)
53.4
(40.8 to 69.8)
Serotype 4; Pre-inj. 2 (N=295,148)
278
(239 to 322)
73.7
(55.2 to 98.5)
Serotype 4; Post-inj. 2 (N=291,147)
395
(341 to 456)
70.4
(53.3 to 92.8)
Serotype 4; Pre-inj. 3 (N=288,143)
259
(227 to 296)
81.8
(62.1 to 108)
Serotype 4; Post-inj. 3 (N=287,143)
341
(299 to 388)
72.5
(55.8 to 94.2)
10.Primary Outcome
Title Summary of Geometric Mean Titers Ratios of Antibodies in Flavivirus-Immune Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Hide Description Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-immune subjects at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer. Geometric mean titer ratio is the geometric mean of individual post vaccination/pre-vaccination titer of antibodies to each parental dengue virus serotype strain.
Time Frame Day 0 (pre each vaccination) and Day 28 post each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
Arm/Group Title Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
Overall Number of Participants Analyzed 316 160
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serotype 1; Post-inj. 1/Pre-inj. 1 (N=305,158)
3.49
(2.94 to 4.15)
0.829
(0.743 to 0.924)
Serotype 1; Post-inj. 2/Pre-inj. 1 (N=293,147)
3.25
(2.73 to 3.88)
1.11
(0.875 to 1.41)
Serotype 1; Post-inj. 2/Pre-inj. 2 (N=293,147)
1.25
(1.10 to 1.43)
0.925
(0.793 to 1.08)
Serotype 1; Post-inj. 3/Pre-inj. 1 (N=287,143)
3.08
(2.61 to 3.64)
1.09
(0.857 to 1.39)
Serotype 1; Post-inj. 3/Pre-inj. 2 (N=287,143)
1.19
(1.05 to 1.35)
0.907
(0.723 to 1.14)
Serotype 1; Post-inj. 3/Pre-inj. 3 (N=287,143)
1.24
(1.15 to 1.34)
0.834
(0.736 to 0.946)
Serotype 2; Post-inj. 1/Pre-inj. 1 (N=305,158)
4.43
(3.74 to 5.24)
0.840
(0.766 to 0.921)
Serotype 2; Post-inj. 2/Pre-inj. 1 (N=293,147)
3.70
(3.08 to 4.44)
1.08
(0.863 to 1.35)
Serotype 2; Post-inj. 2/Pre-inj. 2 (N=293,147)
1.27
(1.12 to 1.44)
0.865
(0.735 to 1.02)
Serotype 2; Post-inj. 3/Pre-inj. 1 (N=287,143)
3.08
(2.59 to 3.67)
1.23
(0.993 to 1.53)
Serotype 2; Post-inj. 3/Pre-inj. 2 (N=287,143)
1.06
(0.939 to 1.20)
0.982
(0.775 to 1.25)
Serotype 2; Post-inj. 3/Pre-inj. 3 (N=287,143)
1.29
(1.18 to 1.40)
0.940
(0.846 to 1.04)
Serotype 3; Post-inj. 1/Pre-inj. 1 (N=305,158)
4.35
(3.67 to 5.15)
0.941
(0.850 to 1.04)
Serotype 3; Post-inj. 2/Pre-inj. 1 (N=293,147)
3.71
(3.13 to 4.39)
1.16
(0.921 to 1.45)
Serotype 3; Post-inj. 2/Pre-inj. 2 (N=293,147)
1.36
(1.20 to 1.55)
0.906
(0.779 to 1.05)
Serotype 3; Post-inj. 3/Pre-inj. 1 (N=287,143)
3.82
(3.27 to 4.47)
1.29
(1.05 to 1.60)
Serotype 3; Post-inj. 3/Pre-inj. 2 (N=287,143)
1.43
(1.27 to 1.62)
1.03
(0.824 to 1.28)
Serotype 3; Post-inj. 3/Pre-inj. 3 (N=287,143)
1.31
(1.22 to 1.40)
0.872
(0.789 to 0.963)
Serotype 4; Post-inj. 1/Pre-inj. 1 (N=305,158)
7.40
(6.03 to 9.08)
0.712
(0.625 to 0.812)
Serotype 4; Post-inj. 2/Pre-inj. 1 (N=291,147)
5.16
(4.31 to 6.19)
0.952
(0.752 to 1.20)
Serotype 4; Post-inj. 2/Pre-inj. 2 (N=291,147)
1.39
(1.22 to 1.57)
0.847
(0.739 to 0.971)
Serotype 4; Post-inj. 3/Pre-inj. 1 (N=287,143)
4.45
(3.76 to 5.26)
0.976
(0.773 to 1.23)
Serotype 4; Post-inj. 3/Pre-inj. 2 (N=287,143)
1.20
(1.06 to 1.36)
0.849
(0.698 to 1.03)
Serotype 4; Post-inj. 3/Pre-inj. 3 (N=287,143)
1.30
(1.21 to 1.40)
0.796
(0.730 to 0.868)
11.Primary Outcome
Title Summary of Geometric Mean Titers (GMTs) of Antibodies in Flavivirus-Naïve Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Hide Description Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavivirus-naïve participants are defined as those participants with < 10 1/dilutions for all serotypes with parental dengue virus strains and for Yellow Fever titer.
Time Frame Day 0 (pre-each vaccination) and Day 28 post-each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
Arm/Group Title Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
Overall Number of Participants Analyzed 85 38
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Serotype 1; Pre-inj. 1 (N=85,38)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Serotype 1; Post-inj. 1 (N=84,37)
5.72
(5.10 to 6.42)
5.15
(4.85 to 5.47)
Serotype 1; Pre-inj. 2 (N=78,36)
8.16
(5.98 to 11.1)
6.18
(4.20 to 9.11)
Serotype 1; Post-inj. 2 (N=78,36)
14.3
(10.0 to 20.3)
7.29
(4.27 to 12.5)
Serotype 1; Pre-inj. 3 (N=77,36)
12.0
(8.48 to 16.9)
7.93
(5.05 to 12.5)
Serotype 1; Post-inj. 3 (N=77,36)
34.6
(25.0 to 48.1)
8.36
(5.31 to 13.2)
Serotype 2; Pre-inj. 1 (N=85,38)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Serotype 2; Post-inj. 1 (N=84,37)
15.9
(11.4 to 22.3)
5.00
(5.00 to 5.00)
Serotype 2; Pre-inj. 2 (N=78,36)
21.0
(14.2 to 31.1)
5.50
(4.54 to 6.66)
Serotype 2; Post-inj. 2 (N=78,36)
60.0
(43.3 to 83.0)
6.79
(4.37 to 10.6)
Serotype 2; Pre-inj. 3 (N=77,36)
30.3
(21.4 to 42.7)
9.48
(5.60 to 16.1)
Serotype 2; Post-inj. 3 (N=77,36)
101
(77.2 to 133)
9.45
(5.78 to 15.4)
Serotype 3; Pre-inj. 1 (N=85,38)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Serotype 3; Post-inj. 1 (N=84,37)
38.8
(25.6 to 59.1)
6.10
(4.89 to 7.60)
Serotype 3; Pre-inj. 2 (N=77,36)
28.6
(20.0 to 41.1)
5.97
(4.75 to 7.50)
Serotype 3; Post-inj. 2 (N=78,36)
94.9
(70.7 to 127)
7.07
(4.41 to 11.3)
Serotype 3; Pre-inj. 3 (N=77,36)
61.9
(44.4 to 86.1)
6.18
(4.58 to 8.34)
Serotype 3; Post-inj. 3 (N=77,36)
174
(136 to 221)
7.53
(5.32 to 10.7)
Serotype 4; Pre-inj. 1 (N=85,38)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Serotype 4; Post-inj. 1 (N=84,37)
151
(89.3 to 255)
5.30
(4.71 to 5.96)
Serotype 4; Pre-inj. 2 (N=78,36)
57.5
(38.8 to 85.1)
5.48
(4.80 to 6.26)
Serotype 4; Post-inj. 2 (N=78,36)
117
(84.8 to 161)
6.77
(4.64 to 9.88)
Serotype 4; Pre-inj. 3 (N=77,36)
48.3
(35.5 to 65.6)
5.97
(4.87 to 7.32)
Serotype 4; Post-inj. 3 (N=77,36)
119
(92.0 to 153)
5.63
(4.76 to 6.65)
12.Primary Outcome
Title Summary of Geometric Mean Titer Ratios of Antibodies in Flavivirus-Naive Participants at Baseline Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Hide Description

Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT).

Flavivirus-naïve participants are defined as those participants with < 10 1/dil for all serotypes with parental dengue virus strains and for Yellow Fever titer. Geometric mean titer ratio is the geometric mean of individual post-vaccination/pre-vaccination titer of antibodies to each parental dengue virus serotype strain.

Time Frame Day 0 (pre-each vaccination) and Day 28 post-each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers against each dengue virus serotype strain were assessed in the Full Analysis Set.
Arm/Group Title Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
Overall Number of Participants Analyzed 85 38
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serotype 1; Post-inj. 1/Pre-inj. 1 (N=84,37)
0.572
(0.510 to 0.642)
0.515
(0.485 to 0.547)
Serotype 1; Post-inj. 2/Pre-inj. 1 (N=78,36)
1.43
(1.00 to 2.03)
0.729
(0.427 to 1.25)
Serotype 1; Post-inj. 2/Pre-inj. 2 (N=78,36)
0.990
(0.773 to 1.27)
0.613
(0.410 to 0.917)
Serotype 1; Post-inj. 3/Pre-inj. 1 (N=77,36)
3.46
(2.50 to 4.81)
0.836
(0.531 to 1.32)
Serotype 1; Post-inj. 3/Pre-inj. 2 (N=77,36)
2.39
(1.78 to 3.22)
0.703
(0.512 to 0.964)
Serotype 1; Post-inj. 3/Pre-inj. 3 (N=77,36)
1.83
(1.48 to 2.26)
0.592
(0.519 to 0.675)
Serotype 2; Post-inj. 1/Pre-inj. 1 (N=84,37)
1.59
(1.14 to 2.23)
0.500
(0.500 to 0.500)
Serotype 2; Post-inj. 2/Pre-inj. 1 (N=78,36)
6.00
(4.33 to 8.30)
0.679
(0.437 to 1.06)
Serotype 2; Post-inj. 2/Pre-inj. 2 (N=78,36)
2.04
(1.50 to 2.77)
0.630
(0.431 to 0.921)
Serotype 2; Post-inj. 3/Pre-inj. 1 (N=77,36)
10.1
(7.72 to 13.3)
0.945
(0.578 to 1.54)
Serotype 2; Post-inj. 3/Pre-inj. 2 (N=77,36)
3.40
(2.35 to 4.91)
0.876
(0.550 to 1.40)
Serotype 2; Post-inj. 3/Pre-inj. 3 (N=77,36)
2.73
(2.23 to 3.33)
0.559
(0.493 to 0.635)
Serotype 3; Post-inj. 1/Pre-inj. 1 (N=84,37)
3.88
(2.56 to 5.91)
0.610
(0.489 to 0.760)
Serotype 3; Post-inj. 2/Pre-inj. 1 (N=78,36)
9.49
(7.07 to 12.7)
0.707
(0.441 to 1.13)
Serotype 3; Post-inj. 2/Pre-inj. 2 (N=77,36)
2.67
(2.13 to 3.35)
0.627
(0.402 to 0.977)
Serotype 3; Post-inj. 3/Pre-inj. 1 (N=77,36)
17.4
(13.6 to 22.1)
0.753
(0.532 to 1.07)
Serotype 3; Post-inj. 3/Pre-inj. 2 (N=76,36)
4.90
(3.68 to 6.53)
0.668
(0.498 to 0.896)
Serotype 3; Post-inj. 3/Pre-inj. 3 (N=77,36)
2.61
(2.16 to 3.16)
0.633
(0.499 to 0.805)
Serotype 4; Post-inj. 1/Pre-inj. 1 (N=84,37)
15.1
(8.93 to 25.5)
0.530
(0.471 to 0.596)
Serotype 4; Post-inj. 2/Pre-inj. 1 (N=78,36)
11.7
(8.48 to 16.1)
0.677
(0.464 to 0.988)
Serotype 4; Post-inj. 2/Pre-inj. 2 (N=78,36)
1.69
(1.31 to 2.17)
0.642
(0.445 to 0.925)
Serotype 4; Post-inj. 3/Pre-inj. 1 (N=77,36)
11.9
(9.20 to 15.3)
0.563
(0.476 to 0.665)
Serotype 4; Post-inj. 3/Pre-inj. 2 (N=77,36)
1.75
(1.31 to 2.34)
0.533
(0.441 to 0.645)
Serotype 4; Post-inj. 3/Pre-inj. 3 (N=77,36)
2.15
(1.74 to 2.64)
0.499
(0.460 to 0.541)
13.Primary Outcome
Title Number of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine
Hide Description Solicited Injection-site reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever, (Temperature) Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection-Site Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥ 5 cm. Grade 3 Solicited Systemic Reactions: Fever, ≥ 39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.
Time Frame Day 0 up to Day 14 post-each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.
Arm/Group Title Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
Overall Number of Participants Analyzed 401 199
Measure Type: Number
Unit of Measure: Participants
Injection-site Pain (Any dose; N=392,198) 192 132
Grade 3 Pain (Any dose; N=392,198) 13 7
Injection-site Erythema (Any dose; N=392,198) 26 18
Grade 3 Erythema (Any dose; N=392,198) 0 1
Injection-site Swelling (Any dose; N=392,198) 20 16
Grade 3 Swelling (Any dose; N=392,198) 1 1
Injection-site Pain (Post-dose 1; N=392,196) 121 54
Grade 3 Pain (Post-dose 1; N=392,196) 6 2
Injection-site Erythema (Post-dose 1; N=390,196) 11 6
Grade 3 Erythema (Post-dose 1; N=390,196) 0 0
Injection-site Swelling (Post-dose 1; N=391,196) 8 5
Grade 3 Swelling (Post-dose 1; N=391,196) 1 0
Injection-site Pain (Post-dose 2; N=373,185) 101 31
Grade Pain (Post-dose 2; N=373,185) 7 0
Injection-site Erythema (Post-dose 2; N=373,185) 12 5
Grade 3 Erythema (Post-dose 2; N=373,185) 0 0
Injection-site Swelling (Post-dose 2; N=373,185) 8 2
Grade 3 Swelling (Post-dose 2; N=373,185) 1 0
Injection-site Pain (Post-dose 3; N=364,180) 88 118
Grade 3 Pain (Post-dose 3; N=364,180) 2 5
Injection-site Erythema (Post-dose 3; N=364,180) 8 16
Grade 3 Erythema (Post-dose 3; N=364,180) 0 1
Injection-site Swelling (Post-dose 3; N=364,180) 6 14
Grade 3 Swelling (Post-dose 3; N=364,180) 0 1
Fever (Any dose; N=392;197) 84 36
Grade 3 Fever (Any dose; N=392;197) 13 3
Headache (Any dose; N=391;198) 237 116
Grade 3 Headache (Any dose; N=391;198) 40 11
Malaise (Any dose; N=390;198) 157 82
Grade 3 Malaise (Any dose; N=390;198) 21 8
Myalgia (Any dose; N=390;198) 171 90
Grade 3 Myalgia (Any dose; N=390;198) 22 10
Asthenia (Any dose; N=390;198) 119 51
Grade 3 Asthenia (Any dose; N=390;198) 14 5
Fever (Post-dose 1; N=392;193) 43 13
Grade 3 Fever (Post dose 1; N=392;193) 11 0
Headache (Post-dose 1; N=391;197) 173 80
Grade 3 Headache (Post-dose 1; N=391;197) 26 5
Malaise (Post-dose 1; N=390;197) 102 45
Grade 3 Malaise (Post-dose 1; N=390;197) 14 0
Myalgia (Post-dose 1; N=390;197) 121 52
Grade 3 Myalgia (Post-dose 1; N=390;197) 15 3
Asthenia (Post-dose 1; N=390;197) 77 30
Grade 3 Asthenia (Post dose 1; N=390;197) 7 2
Fever (Post-dose 2; N=371;184) 29 16
Grade 3 Fever (Post-dose 2; N=371;184) 2 0
Headache (Post-dose 2; N=373;185) 131 69
Grade 3 Headache (Post-dose 2; N=373;185) 14 4
Malaise (Post-dose 2; N=373;185) 68 36
Grade 3 Malaise (Post-dose 2; N=373;185) 6 4
Myalgia (Post dose 2; N=373;185) 80 45
Grade 3 Myalgia (Post-dose 2; N=373;185) 8 3
Asthenia (Post-dose 2; N=373;185) 51 24
Grade 3 Asthenia (Post-dose 2; N=373;185) 5 1
Fever (Post-dose 3; N=362;180) 17 14
Grade 3 Fever (Post-dose 3; N=362;180) 0 3
Headache (Post-dose 3; N=364;180) 106 62
Grade 3 Headache (Post-dose 3; N=364;180) 10 4
Malaise (Post-dose 3; N=364;180) 60 41
Grade 3 Malaise (Post-dose 3; N=364;180) 2 4
Myalgia (Post-dose 3; N=364;180) 66 51
Grade 3 Myalgia (Post-dose 3; N=364;180) 3 5
Asthenia (Post-dose 3; N=364;180) 42 23
Grade 3 Asthenia (Post-dose 3; N=364;180) 2 2
Time Frame Adverse event data were collected from Day 0 (post vaccination) up to Day 28 after each vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dengue Vaccine Group Control Group
Hide Arm/Group Description Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
All-Cause Mortality
Dengue Vaccine Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dengue Vaccine Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/401 (2.49%)      15/199 (7.54%)    
Gastrointestinal disorders     
Gastritis * 1  0/401 (0.00%)  0 1/199 (0.50%)  1
Vomiting * 1  0/401 (0.00%)  0 1/199 (0.50%)  1
Infections and infestations     
Appendicitis * 1  3/401 (0.75%)  3 2/199 (1.01%)  2
Cellulitis * 1  0/401 (0.00%)  0 2/199 (1.01%)  2
Dengue fever * 1  3/401 (0.75%)  3 3/199 (1.51%)  3
Herpes simplex * 1  0/401 (0.00%)  0 1/199 (0.50%)  1
Pneumonia * 1  0/401 (0.00%)  0 1/199 (0.50%)  1
Pyelonephritis * 1  1/401 (0.25%)  1 0/199 (0.00%)  0
Sinusitis * 1  0/401 (0.00%)  0 1/199 (0.50%)  1
Urinary tract infection * 1  1/401 (0.25%)  1 0/199 (0.00%)  0
Injury, poisoning and procedural complications     
Accidental poisoning * 1  1/401 (0.25%)  1 0/199 (0.00%)  0
Hand fracture * 1  0/401 (0.00%)  0 1/199 (0.50%)  1
Head injury * 1  0/401 (0.00%)  0 1/199 (0.50%)  1
Intentional overdose * 1  0/401 (0.00%)  0 1/199 (0.50%)  1
Nervous system disorders     
Convulsion * 1  0/401 (0.00%)  0 1/199 (0.50%)  1
Epilepsy * 1  1/401 (0.25%)  1 0/199 (0.00%)  0
Migraine * 1  0/401 (0.00%)  0 2/199 (1.01%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Dengue Vaccine Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   237/401 (59.10%)      132/199 (66.33%)    
Gastrointestinal disorders     
Abdominal pain * 1  17/401 (4.24%)  19 12/199 (6.03%)  12
Diarrhoea * 1  30/401 (7.48%)  30 9/199 (4.52%)  10
General disorders     
Injection site Pain  1  192/392 (48.98%)  192 132/198 (66.67%)  132
Injection site Erythema  1  26/392 (6.63%)  26 18/198 (9.09%)  18
Injection site Swelling  1  20/392 (5.10%)  20 16/198 (8.08%)  16
Fever  1  84/392 (21.43%)  84 36/197 (18.27%)  36
Malaise  1  157/390 (40.26%)  157 82/198 (41.41%)  82
Asthenia  1  119/390 (30.51%)  119 51/198 (25.76%)  51
Infections and infestations     
Nasopharyngitis * 1  105/401 (26.18%)  124 51/199 (25.63%)  61
Musculoskeletal and connective tissue disorders     
Myalgia  1  171/390 (43.85%)  171 90/198 (45.45%)  90
Nervous system disorders     
Headache * 1  35/401 (8.73%)  40 10/199 (5.03%)  10
Headache  1  237/391 (60.61%)  237 116/198 (58.59%)  116
Respiratory, thoracic and mediastinal disorders     
Cough * 1  24/401 (5.99%)  26 23/199 (11.56%)  24
Rhinitis allergic * 1  14/401 (3.49%)  16 10/199 (5.03%)  10
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00993447     History of Changes
Other Study ID Numbers: CYD13
UTN: U1111-1111-5511
First Submitted: October 9, 2009
First Posted: October 12, 2009
Results First Submitted: October 4, 2016
Results First Posted: November 29, 2016
Last Update Posted: November 29, 2016