Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01187433
Recruitment Status : Completed
First Posted : August 24, 2010
Results First Posted : November 11, 2016
Last Update Posted : November 11, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Dengue
Dengue Hemorrhagic Fever
Interventions Biological: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus
Biological: NaCl 0.9%
Biological: Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed
Biological: Meningococcal A+C vaccine
Enrollment 150
Recruitment Details Study participants were enrolled from 20 August 2010 to 8 December 2011 at 1 clinical site in Brazil.
Pre-assignment Details A total of 150 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Period Title: Overall Study
Started 100 50
Completed 89 46
Not Completed 11 4
Reason Not Completed
Protocol Violation             6             2
Withdrawal by Subject             5             2
Arm/Group Title CYD Dengue Vaccine Group Control Group Total
Hide Arm/Group Description Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. Total of all reporting groups
Overall Number of Baseline Participants 100 50 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 50 participants 150 participants
<=18 years
100
 100.0%
50
 100.0%
150
 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
Age Continuous Number Analyzed 100 participants 50 participants 150 participants
12.7  (2.1) 12.7  (2.2) 12.7  (2.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 50 participants 150 participants
Female
59
  59.0%
23
  46.0%
82
  54.7%
Male
41
  41.0%
27
  54.0%
68
  45.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 100 participants 50 participants 150 participants
100 50 150
1.Primary Outcome
Title Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Hide Description Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Time Frame Before and 28 days after each injection
Hide Outcome Measure Data
Hide Analysis Population Description
Seropositivity was assessed in the Full Analysis Set.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 99 49
Measure Type: Number
Unit of Measure: Percentage of participants
Serotype 1; Pre-Injection 1 (n=99, 49) 59.6 63.3
Serotype 1; Post-Injection 1 (n=99, 49) 79.8 69.4
Serotype 1; Pre-Injection 2 (n=94, 47) 80.9 72.3
Serotype 1; Post Injection 2 (n=94, 47) 95.7 72.3
Serotype 1; Pre-Injection 3 (n=90, 46) 78.9 69.6
Serotype 1; Post-Injection 3 (n=89, 46) 96.6 69.6
Serotype 2; Pre-Injection 1 (n=99, 49) 65.7 67.3
Serotype 2; Post-Injection 1 (n=99, 49) 80.8 67.3
Serotype 2; Pre-Injection 2 (n=94, 47) 80.9 74.5
Serotype 2; Post-Injection 2 (n=94, 47) 98.9 72.3
Serotype 2; Pre-Injection 3 (n=90, 46) 85.6 76.1
Serotype 2; Post-Injection 3 (n=89, 46) 98.9 76.1
Serotype 3; Pre-Injection 1 (n=99, 49) 62.6 65.3
Serotype 3; Post-Injection 1 (n=99, 49) 92.9 67.3
Serotype 3; Pre-Injection 2 (n=94, 47) 89.4 72.3
Serotype 3; Post-Injection 2 (n=94, 47) 100.0 72.3
Serotype 3; Pre-Injection 3 (n=89, 46) 94.4 71.7
Serotype 3; Post-Injection 3 (n=89, 46) 100.0 73.9
Serotype 4; Pre-Injection 1 (n=99, 49) 47.5 51
Serotype 4; Post -njection 1 (n=99, 48) 89.9 58.3
Serotype 4; Pre-Injection 2 (n=94, 47) 92.6 57.4
Serotype 4; Post-Injection 2 (n=94, 47) 100.0 59.6
Serotype 4; Pre-Injection 3 (n=88, 46) 97.7 69.6
Serotype 4; Post-Injection 3 (n=89, 46) 100.0 73.9
2.Primary Outcome
Title Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Hide Description Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.
Time Frame Before and 28 days after each injection
Hide Outcome Measure Data
Hide Analysis Population Description
Seropositivity was assessed in the Full Analysis Set.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 80 41
Measure Type: Number
Unit of Measure: Percentage of participants
Serotype 1; Pre-Injection 1 (n=80, 41) 73.8 75.6
Serotype 1; Post-Injection 1 (n=80, 41) 88.8 82.9
Serotype 1; Pre-Injection 2 (n=78, 39) 91.0 87.2
Serotype 1; Post-Injection 2 (n=78, 39) 100.0 87.2
Serotype 1; Pre-Injection 3 (n=74, 38) 87.8 81.6
Serotype 1; Post-Injection 3 (n=73, 38) 98.6 81.6
Serotype 2; Pre-Injection 1 (n=80, 41) 81.3 80.5
Serotype 2; Post-Injection 1 (n=80, 41) 93.8 80.5
Serotype 2; Pre-Injection 2 (n=78, 39) 92.3 89.7
Serotype 2; Post-Injection 2 (n=78, 39) 100.0 87.2
Serotype 2; Pre-Injection 3 (n=74, 38) 91.9 89.5
Serotype 2; Post-Injection 3 (n=73, 38) 100.0 89.5
Serotype 3; Pre-Injection 1 (n=80, 41) 77.5 78
Serotype 3; Post-Injection 1 (n=80, 41) 95.0 80.5
Serotype 3; Pre-Injection 2 (n=78, 39) 93.6 87.2
Serotype 3; Post-Injection 2 (n=78, 39) 100.0 87.2
Serotype 3; Pre-Injection 3 (n=74, 38) 97.3 84.2
Serotype 3; Post-Injection 3 (n=73, 38) 100.0 86.8
Serotype 4; Pre-Injection 1 (n=80, 41) 58.8 61
Serotype 4; Post-Injection 1 (n=80, 40) 95.0 70
Serotype 4; Pre-Injection 2 (n=78, 39) 94.9 69.2
Serotype 4; Post-Injection 2 (n=78, 39) 100.0 71.8
Serotype 4; Pre-Injection 3 (n=73, 38) 98.6 81.6
Serotype 4; Post-Injection 3 (n=73, 38) 100.0 84.2
3.Primary Outcome
Title Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Hide Description Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.
Time Frame Before and 28 Days after each injection
Hide Outcome Measure Data
Hide Analysis Population Description
Seropositivity was assessed in the Full Analysis Set.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 19 8
Measure Type: Number
Unit of Measure: Percentage of participants
Serotype 1; Pre-Injection 1 (n=19, 8) 0.0 0
Serotype 1; Post-Injection 1 (n=19, 8) 42.1 0
Serotype 1; Pre-Injection 2 (n=16, 8) 31.3 0
Serotype 1; Post-Injection 2 (n=16, 8) 75.0 0
Serotype 1; Pre-Injection 3 (n=16, 8) 37.5 12.5
Serotype 1; Post-Injection 3 (n=16, 8) 87.5 12.5
Serotype 2; Pre-Injection 1 (n=19, 8) 0.0 0
Serotype 2; Post-Injection 1 (n=19, 8) 26.3 0
Serotype 2; Pre-Injection 2 (n=16, 8) 25.0 0
Serotype 2; Post-Injection 2 (n=16, 8) 93.8 0
Serotype 2; Pre-Injection 3 (n=16, 8) 56.3 12.5
Serotype 2; Post-Injection 3 (n=16, 8) 93.8 12.5
Serotype 3; Pre-Injection 1 (n=19, 8) 0.0 0
Serotype 3; Post-Injection 1 (n=19, 8) 84.2 0
Serotype 3; Pre-Injection 2 (n=16, 8) 68.8 0
Serotype 3; Post-Injection 2 (n=16, 8) 100.0 0
Serotype 3; Pre-Injection 3 (n=15, 8) 80.0 12.5
Serotype 3; Post-Injection 3 (n=16, 8) 100.0 12.5
Serotype 4; Pre-Injection 1 (n=19, 8) 0.0 0
Serotype 4; Post-Injection 1 (n=19, 8) 68.4 0
Serotype 4; Pre-Injection 2 (n=16, 8) 81.3 0
Serotype 4; Post-Injection 2 (n=16, 8) 100.0 0
Serotype 4; Pre-Injection 3 (n=15, 8) 93.3 12.5
Serotype 4; Post-Injection 3 (n=16, 8) 100.0 25
4.Primary Outcome
Title Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Hide Description Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Time Frame Before and 28 days after each injection
Hide Outcome Measure Data
Hide Analysis Population Description
Seropositivity was assessed in the Full Analysis Set.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 99 49
Measure Type: Number
Unit of Measure: Percentage of participants
At least 1 serotype; Pre-Injection 1 (n=99, 49) 68.7 71.4
At least 1 serotype; Post-Injection 1 (n=99, 49) 97.0 71.4
At least 1 serotype; Pre-Injection 2 (n=94, 47) 94.7 74.5
At least 1 serotype; Post-Injection 2 (n=94, 47) 100.0 74.5
At least 1 serotype; Pre-Injection 3 (n=90, 46) 98.9 78.3
At least 1 serotype; Post-Injection 3 (n=89, 46) 100.0 78.3
At least 2 serotypes; Pre-Injection 1 (n=99, 49) 62.6 67.3
At least 2 serotypes; Post-Injection 1 (n=99, 49) 91.9 71.4
At least 2 serotypes; Pre-Injection 2 (n=94, 47) 92.6 74.5
At least 2 serotypes; Post-Injection 2 (n=94, 47) 100.0 72.3
At least 2 serotypes; Pre-Injection 3 (n=90, 46) 91.1 73.9
At least 2 serotypes; Post-Injection 3 (n=89, 46) 100.0 76.1
At least 3 serotypes; Pre-Injection 1 (n=99, 49) 56.6 61.2
At least 3 serotypes; Post-Injection 1 (n=99, 49) 81.8 65.3
At least 3 serotypes; Pre-Injection 2 (n=94, 47) 81.9 72.3
At least 3 serotypes; Post-Injection 2 (n=94, 47) 98.9 70.2
At least 3 serotypes; Pre-Injection 3 (n=90, 46) 86.7 71.7
At least 3 serotypes; Post-Injection 3 (n=89, 46) 98.9 71.7
All 4 serotypes; Pre-Injection 1 (n=99, 49) 47.5 46.9
All 4 serotypes; Post-Injection 1 (n=99, 49) 72.7 53.1
All 4 serotypes; Pre-Injection 2 (n=94, 47) 74.5 55.3
All 4 serotypes; Post-Injection 2 (n=94, 47) 95.7 59.6
All 4 serotypes; Pre-Injection 3 (n=90, 46) 76.7 63
All 4 serotypes; Post-Injection 3 (n=89, 46) 96.6 67.4
5.Primary Outcome
Title Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Hide Description Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.
Time Frame Before and 28 days after each injection
Hide Outcome Measure Data
Hide Analysis Population Description
Seropositivity was assessed in the Full Analysis Set.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 80 41
Measure Type: Number
Unit of Measure: Percentage of participants
At least 1 serotype; Pre-Injection 1 (n=80, 41) 85.0 85.4
At least 1 serotype; Post-Injection 1 (n=80, 41) 97.5 85.4
At least 1 serotype; Pre-Injection 2 (n=78, 39) 97.4 89.7
At least 1 serotype; Post-Injection 2 (n=78, 39) 100.0 89.7
At least 1 serotype; Pre-Injection 3 (n=74, 38) 100.0 92.1
At least 1 serotype; Post-Injection 3 (n=73, 38) 100.0 89.5
At least 2 serotypes; Pre-Injection 1 (n=80, 41) 77.5 80.5
At least 2 serotypes; Post-Injection 1 (n=80, 41) 95.0 85.4
At least 2 serotypes; Pre-Injection 2 (n=78, 39) 97.4 89.7
At least 2 serotypes; Post-Injection 2 (n=78, 39) 100.0 87.2
At least 2 serotypes; Pre-Injection 3 (n=74, 38) 95.9 86.8
At least 2 serotypes; Post-Injection 3 (n=73, 38) 100.0 89.5
At least 3 serotypes; Pre-Injection 1 (n=80, 41) 70.0 73.2
At least 3 serotypes; Post-Injection 1 (n=80, 41) 92.5 78
At least 3 serotypes; Pre-Injection 2 (n=78, 39) 91.0 87.2
At least 3 serotypes; Post-Injection 2 (n=78, 39) 100.0 84.6
At least 3 serotypes; Pre-Injection 3 (n=74, 38) 93.2 84.2
At least 3 serotypes; Post-Injection 3 (n=73, 38) 100.0 84.2
All 4 serotypes; Pre-Injection 1 (n=80, 41) 58.8 56.1
All 4 serotypes; Post-Injection 1 (n=80, 41) 87.5 63.4
All 4 serotypes; Pre-Injection 2 (n=78, 39) 85.9 66.7
All 4 serotypes; Post-Injection 2 (n=78, 39) 100.0 71.8
All 4 serotypes; Pre-Injection 3 (n=74, 38) 85.1 73.7
All 4 serotypes; Post-Injection 3 (n=73, 38) 98.6 78.9
6.Primary Outcome
Title Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Hide Description Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.
Time Frame Before and 28 days after each injection
Hide Outcome Measure Data
Hide Analysis Population Description
Seropositivity was assessed in the Full Analysis Set.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 19 8
Measure Type: Number
Unit of Measure: Percentage of participants
At least 1 serotype; Pre-Injection 1 (n=19, 8) 0.0 0
At least 1 serotype; Post-Injection 1 (n=19, 8) 94.7 0
At least 1 serotype; Pre-Injection 2 (n=16, 8) 81.3 0
At least 1 serotype; Post-Injection 2 (n=16, 8) 100.0 0
At least 1 serotype; Pre-Injection 3 (n=16, 8) 93.8 12.5
At least 1 serotype; Post-Injection 3 (n=16, 8) 100.0 25
At least 2 serotypes; Pre-Injection 1 (n=19, 8) 0.0 0
At least 2 serotypes; Post-Injection 1 (n=19, 8) 78.9 0
At least 2 serotypes; Pre-Injection 2 (n=16, 8) 68.8 0
At least 2 serotypes; Post-Injection 2 (n=16, 8) 100.0 0
At least 2 serotypes; Pre-Injection 3 (n=16, 8) 68.8 12.5
At least 2 serotypes; Post-Injection 3 (n=16, 8) 100.0 12.5
At least 3 serotypes; Pre-Injection 1 (n=19, 8) 0.0 0
At least 3 serotypes; Post-Injection 1 (n=19, 8) 36.8 0
At least 3 serotypes; Pre-Injection 2 (n=16, 8) 37.5 0
At least 3 serotypes; Post-Injection 2 (n=16, 8) 93.8 0
At least 3 serotypes; Pre-Injection 3 (n=16, 8) 56.3 12.5
At least 3 serotypes; Post-Injection 3 (n=16, 8) 93.8 12.5
All 4 serotypes; Pre-Injection 1 (n=19, 8) 0.0 0
All 4 serotypes; Post-Injection 1 (n=19, 8) 10.5 0
All 4 serotypes; Pre-Injection 2 (n=16, 8) 18.8 0
All 4 serotypes; Post-Injection 2 (n=16, 8) 75.0 0
All 4 serotypes; Pre-Injection 3 (n=16, 8) 37.5 12.5
All 4 serotypes; Post-Injection 3 (n=16, 8) 87.5 12.5
7.Primary Outcome
Title Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Hide Description Geometric mean titer ratios were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Time Frame Before and 28 days after each injection
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titer ratios were assessed in the Full Analysis Set.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 99 49
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer ratio
Serotype 1; Post-Inj. 1 / Pre-Inj. 1 (n=99, 49)
4.67
(3.37 to 6.47)
0.834
(0.699 to 0.994)
Serotype 1; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47)
7.26
(5.51 to 9.57)
2.11
(1.12 to 4)
Serotype 1; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47)
1.66
(1.31 to 2.10)
1.25
(0.801 to 1.94)
Serotype 1; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46)
4.92
(3.71 to 6.52)
1.36
(0.797 to 2.31)
Serotype 1; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46)
1.07
(0.828 to 1.39)
0.793
(0.508 to 1.24)
Serotype 1; Post -nj. 3 / Pre-Inj. 3 (n=89, 46)
1.48
(1.25 to 1.74)
0.706
(0.607 to 0.821)
Serotype 2; Post-Inj. 1 / Pre-Inj. 1 (n=99, 49)
4.15
(3.07 to 5.59)
0.733
(0.639 to 0.84)
Serotype 2; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47)
6.80
(5.46 to 8.45)
1.75
(0.956 to 3.21)
Serotype 2; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47)
1.97
(1.56 to 2.50)
0.981
(0.66 to 1.46)
Serotype 2; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46)
6.21
(4.96 to 7.78)
1.68
(1.06 to 2.66)
Serotype 2; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46)
1.78
(1.39 to 2.28)
0.944
(0.646 to 1.38)
Serotype 2; Post-Inj. 3 / Pre-Inj. 3 (n=89, 46)
1.40
(1.16 to 1.69)
0.851
(0.734 to 0.986)
Serotype 3; Post-Inj. 1 / Pre-Inj. 1 (n=99, 49)
6.50
(5.01 to 8.45)
0.916
(0.673 to 1.25)
Serotype 3; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47)
8.57
(6.79 to 10.8)
1.85
(1.03 to 3.32)
Serotype 3; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47)
2.03
(1.58 to 2.61)
1.02
(0.701 to 1.47)
Serotype 3; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46)
6.26
(4.82 to 8.13)
1.24
(0.815 to 1.9)
Serotype 3; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46)
1.46
(1.11 to 1.91)
0.673
(0.489 to 0.925)
Serotype 3; Post-Inj. 3 / Pre-Inj. 3 (n=88, 46)
1.53
(1.27 to 1.86)
0.8
(0.681 to 0.94)
Serotype 4; Post-Inj. 1 / Pre-Inj. 1 (n=99, 48)
17.7
(12.1 to 26.0)
0.806
(0.665 to 0.976)
Serotype 4; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47)
15.4
(12.3 to 19.2)
1.27
(0.795 to 2.04)
Serotype 4; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47)
1.84
(1.50 to 2.26)
0.835
(0.587 to 1.19)
Serotype 4; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46)
20.2
(15.4 to 26.3)
1.4
(0.939 to 2.1)
Serotype 4; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46)
2.26
(1.74 to 2.93)
0.912
(0.606 to 1.37)
Serotype 4; Post -nj. 3 / Pre-Inj. 3 (n=87, 46)
1.68
(1.38 to 2.05)
0.723
(0.564 to 0.927)
8.Primary Outcome
Title Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Hide Description Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Time Frame Before and 28 days after each injection
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the Full Analysis Set.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 99 49
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilutions)
Serotype 1; Pre-Injection 1 (n=99, 49)
41.4
(27.7 to 62.1)
47.2
(26.9 to 82.7)
Serotype 1; Post-Injection 1 (n=99, 49)
256
(151 to 433)
50.7
(29.5 to 87.3)
Serotype 1; Pre-Injection 2 (n=94, 47)
230
(138 to 384)
86
(43.8 to 169)
Serotype 1; Post-Injection 2 (n=94, 47)
436
(287 to 662)
130
(59.7 to 283)
Serotype 1; Pre-Injection 3 (n=90, 46)
162
(99.8 to 262)
90.8
(46.6 to 177)
Serotype 1; Post-Injection 3 (n=89, 46)
267
(181 to 394)
79.2
(42.4 to 148)
Serotype 2; Pre-Injection 1 (n=99, 49)
67.0
(44.0 to 102)
68.3
(36.3 to 129)
Serotype 2; Post-Injection 1 (n=99, 49)
352
(210 to 592)
62.8
(33.9 to 116)
Serotype 2; Pre-Injection 2 (n=94, 47)
287
(173 to 475)
117
(57.6 to 238)
Serotype 2; Post-Injection 2 (n=94, 47)
647
(449 to 932)
137
(61.4 to 306)
Serotype 2; Pre-Injection 3 (n=90, 46)
360
(219 to 592)
131
(65.7 to 262)
Serotype 2; Post-Injection 3 (n=89, 46)
544
(378 to 782)
132
(67 to 259)
Serotype 3; Pre-Injection 1 (n=99, 49)
81.9
(49.3 to 136)
94.7
(43.6 to 206)
Serotype 3; Post-Injection 1 (n=99, 49)
690
(423 to 1125)
110
(50.3 to 242)
Serotype 3; Pre-Injection 2 (n=94, 47)
471
(282 to 787)
184
(80.3 to 424)
Serotype 3; Post-Injection 2 (n=94, 47)
1031
(704 to 1512)
227
(92.8 to 556)
Serotype 3; Pre-Injection 3 (n=89, 46)
481
(300 to 772)
144
(65.8 to 316)
Serotype 3; Post-Injection 3 (n=89, 46)
741
(516 to 1062)
140
(66 to 298)
Serotype 4; Pre-Injection 1 (n=99, 49)
15.0
(11.6 to 19.4)
17.5
(11.9 to 25.8)
Serotype 4; Post-Injection 1 (n=99, 48)
383
(262 to 559)
19.2
(13.3 to 27.7)
Serotype 4; Pre-Injection 2 (n=94, 47)
178
(134 to 238)
27.8
(16.9 to 45.8)
Serotype 4; Post-Injection 2 (n=94, 47)
346
(281 to 425)
31.2
(18.1 to 53.7)
Serotype 4; Pre-Injection 3 (n=88, 46)
258
(192 to 347)
37.4
(22.6 to 62.1)
Serotype 4; Post-Injection 3 (n=89, 46)
432
(335 to 556)
33.4
(21.5 to 51.9)
9.Primary Outcome
Title Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Hide Description Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.
Time Frame Before and 28 days after each injection
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were assessed in the Full Analysis Set.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 80 41
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilutions)
Serotype 1; Pre-Injection 1 (n=80, 41)
68.5
(44.5 to 105)
73.1
(40.9 to 131)
Serotype 1; Post-Injection 1 (n=80, 41)
549
(328 to 918)
79.8
(46.1 to 138)
Serotype 1; Pre-Injection 2 (n=78, 39)
430
(261 to 709)
154
(78.5 to 303)
Serotype 1; Post-Injection 2 (n=78, 39)
661
(442 to 987)
253
(116 to 553)
Serotype 1; Pre-Injection 3 (n=74, 38)
268
(164 to 435)
143
(73.7 to 278)
Serotype 1; Post-Injection 3 (n=73, 38)
381
(256 to 566)
126
(67.6 to 236)
Serotype 2; Pre-Injection 1 (n=80, 41)
124
(81.9 to 188)
114
(59.7 to 217)
Serotype 2; Post-Injection 1 (n=80, 41)
816
(517 to 1290)
103
(54.8 to 193)
Serotype 2; Pre-Injection 2 (n=78, 39)
591
(376 to 928)
224
(112 to 446)
Serotype 2; Post-Injection 2 (n=78, 39)
978
(697 to 1374)
271
(120 to 610)
Serotype 2; Pre-Injection 3 (n=74, 38)
648
(400 to 1048)
240
(122 to 471)
Serotype 2; Post-Injection 3 (n=73, 38)
835
(584 to 1193)
242
(126 to 463)
Serotype 3; Pre-Injection 1 (n=80, 41)
159
(93.5 to 271)
168
(74.3 to 380)
Serotype 3; Post-Injection 1 (n=80, 41)
1263
(764 to 2088)
202
(89.3 to 455)
Serotype 3; Pre-Injection 2 (n=78, 39)
879
(531 to 1455)
387
(170 to 878)
Serotype 3; Post-Injection 2 (n=78, 39)
1426
(950 to 2141)
497
(204 to 1210)
Serotype 3; Pre-Injection 3 (n=74, 38)
776
(481 to 1251)
272
(122 to 606)
Serotype 3; Post-Injection 3 (n=73, 38)
1031
(700 to 1519)
266
(125 to 566)
Serotype 4; Pre-Injection 1 (n=80, 41)
19.5
(14.6 to 26.1)
22.4
(14.6 to 34.3)
Serotype 4; Post-Injection 1 (n=80, 40)
467
(325 to 672)
25.2
(17.1 to 37.1)
Serotype 4; Pre-Injection 2 (n=78, 39)
220
(164 to 295)
39.5
(23.1 to 67.6)
Serotype 4; Post-Injection 2 (n=78, 39)
377
(303 to 470)
45.3
(25.1 to 81.8)
Serotype 4; Pre-Injection 3 (n=73, 38)
313
(231 to 424)
53.9
(31.7 to 91.8)
Serotype 4; Post-Injection 3 (n=73, 38)
485
(374 to 628)
46.5
(29.3 to 73.6)
10.Primary Outcome
Title Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Hide Description Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.
Time Frame Before and 28 days after each injection
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titer ratios were assessed in the Full Analysis Set.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 19 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer ratio
Serotype 1; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8)
1.03
(0.639 to 1.67)
0.5
(0.5 to 0.5)
Serotype 1; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8)
5.73
(1.89 to 17.3)
0.5
(0.5 to 0.5)
Serotype 1; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8)
3.25
(1.18 to 8.93)
0.5
(0.5 to 0.5)
Serotype 1; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8)
5.34
(2.25 to 12.7)
0.861
(0.238 to 3.11)
Serotype 1; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8)
3.03
(1.35 to 6.80)
0.861
(0.238 to 3.11)
Serotype 1; Post-Inj. 3 / Pre-Inj. 3 (n=16, 8)
2.19
(1.37 to 3.48)
0.446
(0.342 to 0.584)
Serotype 2; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8)
1.02
(0.527 to 1.99)
0.5
(0.5 to 0.5)
Serotype 2; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8)
8.62
(3.49 to 21.3)
0.5
(0.5 to 0.5)
Serotype 2; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8)
6.02
(2.37 to 15.3)
0.5
(0.5 to 0.5)
Serotype 2; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8)
7.67
(4.19 to 14.0)
0.737
(0.294 to 1.85)
Serotype 2; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8)
5.36
(2.73 to 10.5)
0.737
(0.294 to 1.85)
Serotype 2; Post -nj. 3 / Pre-Inj. 3 (n=16, 8)
2.37
(1.35 to 4.17)
0.538
(0.453 to 0.639)
Serotype 3; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8)
5.41
(2.80 to 10.5)
0.5
(0.5 to 0.5)
Serotype 3; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8)
21.2
(10.5 to 42.9)
0.5
(0.5 to 0.5)
Serotype 3; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8)
7.58
(3.12 to 18.4)
0.5
(0.5 to 0.5)
Serotype 3; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8)
16.3
(9.65 to 27.7)
0.678
(0.33 to 1.39)
Serotype 3; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8)
5.83
(3.17 to 10.7)
0.678
(0.33 to 1.39)
Serotype 3; Post-Inj. 3 / Pre-Inj. 3 (n=15, 8)
3.35
(1.92 to 5.84)
0.524
(0.469 to 0.587)
Serotype 4; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8)
16.5
(4.58 to 59.1)
0.5
(0.5 to 0.5)
Serotype 4; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8)
22.7
(12.8 to 40.3)
0.5
(0.5 to 0.5)
Serotype 4; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8)
3.15
(1.63 to 6.09)
0.5
(0.5 to 0.5)
Serotype 4; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8)
25.5
(11.6 to 55.9)
0.701
(0.414 to 1.19)
Serotype 4; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8)
3.53
(1.71 to 7.26)
0.701
(0.414 to 1.19)
Serotype 4; Post-Inj. 3 / Pre-Inj. 3 (n=15, 8)
2.55
(1.37 to 4.75)
0.578
(0.401 to 0.832)
11.Primary Outcome
Title Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Hide Description Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Injection-site reactions (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Injection site reactions (≥12 years): Pain, Significant; prevents daily activity; Erythema and Swelling, >10 cm. Grade 3 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 and systemic reactions were assessed in the Safety Analysis Set.
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description:
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
Overall Number of Participants Analyzed 100 50
Measure Type: Number
Unit of Measure: Percentage of participants
Injection-site Pain; Post-Any Injection (N=100,49) 40 40.8
Grade 3 Inj.-site Pain; Post-Any Inj. (N=100,49) 0 4.1
Inj.-site Erythema; Post-Any Inj. (N=100,49) 4.0 2
Gr 3 Inj.-site Erythema; Post-Any Inj. (N=100,49) 0 0
Inj.-site Swelling; Post-Any Inj. (N=100,49) 5.0 4.1
Gr 3 Inj.-site Swelling; Post-Any Inj. (N=100,49) 0 0
Injection-site Pain; Post-Injection 1 (N=99,49) 26.3 30.6
Gr 3 Inj.-site Pain; Post-Inj. 1 (N=99,49) 0 2
Inj.-site Erythema; Post-Inj. 1 (N=99,49) 1.0 2
Gr 3 Inj.-site Erythema; Post-Inj. 1 (N=99,49) 0 0
Inj.-site Swelling; Post-Inj. 1 (N=99,49) 2.0 4.1
Gr 3 Inj.-site Swelling; Post-Inj. 1 (N=99,49) 0 0
Injection-site Pain; Post-Injection 2 (N=93,47) 21.5 14.9
Gr 3 Inj.-site Pain; Post-Inj. 2 (N=93,47) 0 2.1
Inj.-site Erythema; Post-Inj. 2 (N=93,47) 3.2 0
Gr 3 Inj.-site Erythema; Post-Inj. 2 (N=93,47) 0 0
Inj.-site Swelling; Post-Inj. 2 (N=93,47) 2.2 0
Gr 3 Inj.-site Swelling; Post-Inj. 2 (N=93,47) 0 0
Injection-site Pain; Post-Injection 3 (N=89,45) 16.9 15.6
Gr 3 Inj.-site Pain; Post-Inj. 3 (N=89,45) 0 2.2
Inj.-site Erythema; Post-Inj. 3 (N=89,45) 0 0
Gr 3 Inj.-site Erythema; Post-Inj. 3 (N=89,45) 0 0
Inj.-site Swelling; Post-Inj. 3 (N=89,45) 1.1 0
Gr 3 Inj.-site Swelling; Post-Inj. 3 (N=89,45) 0 0
Fever; Post-Any Injection (N=100, 49) 30.0 18.4
Grade 3 Fever; Post-Any Injection (N=100, 49) 8.0 6.1
Headache; Post-Any Injection (N=100, 49) 61.0 51
Grade 3 Headache; Post-Any Injection (N=100, 49) 15.0 20.4
Malaise; Post-Any Injection (N=100, 49) 40.0 32.7
Grade 3 Malaise; Post-Any Injection (N=100, 49) 11.0 6.1
Myalgia; Post-Any Injection (N=100, 49) 42.0 42.9
Grade 3 Myalgia; Post-Any Injection (N=100, 49) 6.0 8.2
Asthenia; Post-Any Injection (N=100, 49) 35.0 20.4
Grade 3 Asthenia; Post-Any Injection (N=100, 49) 8.0 4.1
Fever; Post-Injection 1 (N=98, 48) 15.3 10.4
Grade 3 Fever; Post-Injection 1 (N=98, 48) 3.1 2.1
Headache; Post-Injection 1 (N=99, 49) 48.5 40.8
Grade 3 Headache; Post-Injection 1 (N=99, 49) 8.1 10.2
Malaise; Post-Injection 1 (N=99, 49) 31.3 18.4
Grade 3 Malaise; Post-Injection 1 (N=99, 49) 3.0 2
Myalgia; Post-Injection 1 (N=99, 49) 32.3 30.6
Grade 3 Myalgia; Post-Injection 1 (N=99, 49) 2.0 6.1
Asthenia; Post-Injection 1 (N=99, 49) 22.2 10.2
Grade 3 Asthenia; Post-Injection 1 (N=99, 49) 4.0 4.1
Fever; Post-Injection 2 (N=92, 47) 8.7 4.3
Grade 3 Fever; Post-Injection 2 (N=92, 47) 2.2 0
Headache; Post-Injection 2 (N=94, 47) 28.7 34
Grade 3 Headache; Post-Injection 2 (N=94, 47) 5.3 6.4
Malaise; Post-Injection 2 (N=94, 47) 18.1 17
Grade 3 Malaise; Post-Injection 2 (N=94, 47) 6.4 4.3
Myalgia; Post-Injection 2 (N=94, 47) 20.2 21.3
Grade 3 Myalgia; Post-Injection 2 (N=94, 47) 3.2 4.3
Asthenia; Post-Injection 2 (N=94, 47) 12.8 14.9
Grade 3 Asthenia; Post-Injection 2 (N=94, 47) 3.2 0
Fever; Post-Injection 3 (N=82, 43) 11.0 7
Grade 3 Fever; Post-Injection 3 (N=82, 43) 3.7 7
Headache; Post-Injection 3 (N=89, 45) 27.0 20
Grade 3 Headache; Post-Injection 3 (N=89, 45) 5.6 8.9
Malaise; Post-Injection 3 (N=89, 45) 15.7 11.1
Grade 3 Malaise; Post-Injection 3 (N=89, 45) 2.2 0
Myalgia; Post-Injection 3 (N=89, 45) 20.2 11.1
Grade 3 Myalgia; Post-Injection 3 (N=89, 45) 2.2 0
Asthenia; Post-Injection 3 (N=89, 45) 14.6 4.4
Grade 3 Asthenia; Post-Injection 3 (N=89, 45) 2.2 0
Time Frame Adverse events were collected from Day 0 (post-vaccination) up to Day 14 post-Injection 3
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CYD Dengue Vaccine Group Control Group
Hide Arm/Group Description Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
All-Cause Mortality
CYD Dengue Vaccine Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CYD Dengue Vaccine Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/100 (5.00%)      3/50 (6.00%)    
Gastrointestinal disorders     
Abdominal pain * 1  0/100 (0.00%)  0 1/50 (2.00%)  1
Food poisoning * 1  1/100 (1.00%)  1 0/50 (0.00%)  0
Infections and infestations     
Abdominal wall abscess * 1  1/100 (1.00%)  1 0/50 (0.00%)  0
Appendicitis * 1  1/100 (1.00%)  1 1/50 (2.00%)  1
Cellulitis * 1  2/100 (2.00%)  2 0/50 (0.00%)  0
Gastroenteritis * 1  0/100 (0.00%)  0 1/50 (2.00%)  1
Injury, poisoning and procedural complications     
Multiple injuries * 1  0/100 (0.00%)  0 1/50 (2.00%)  1
Pregnancy, puerperium and perinatal conditions     
Intra uterine death * 1  1/100 (1.00%)  1 0/50 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
CYD Dengue Vaccine Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   61/100 (61.00%)      25/50 (50.00%)    
Blood and lymphatic system disorders     
Lymphadenopathy * 1  9/100 (9.00%)  9 1/50 (2.00%)  2
Eye disorders     
Conjunctivitis * 1  11/100 (11.00%)  11 7/50 (14.00%)  7
Gastrointestinal disorders     
Abdominal pain * 1  12/100 (12.00%)  16 4/50 (8.00%)  6
Nausea * 1  8/100 (8.00%)  11 0/50 (0.00%)  0
Vomiting * 1  7/100 (7.00%)  7 2/50 (4.00%)  2
General disorders     
Injection site Pain; Post Any Injection  1  40/100 (40.00%)  40 20/49 (40.82%)  20
Injection site Swelling; Post Any Injection  1  5/100 (5.00%)  5 2/49 (4.08%)  2
Fever; Post Any Injection  1  30/100 (30.00%)  30 9/49 (18.37%)  9
Malaise; Post-Any Injection  1  40/100 (40.00%)  40 16/49 (32.65%)  16
Asthenia; Post-Any Injection  1  35/100 (35.00%)  35 10/49 (20.41%)  10
Infections and infestations     
Nasopharyngitis * 1  12/100 (12.00%)  12 6/50 (12.00%)  6
Rhinitis * 1  6/100 (6.00%)  7 2/50 (4.00%)  2
Tonsillitis * 1  5/100 (5.00%)  5 0/50 (0.00%)  0
Upper respiratory tract infection * 1  18/100 (18.00%)  19 3/50 (6.00%)  3
Injury, poisoning and procedural complications     
Limb injury * 1  6/100 (6.00%)  6 4/50 (8.00%)  4
Wound * 1  0/100 (0.00%)  0 3/50 (6.00%)  3
Musculoskeletal and connective tissue disorders     
Myalgia; Post-Any Injection  1  42/100 (42.00%)  42 21/49 (42.86%)  21
Nervous system disorders     
Headache: Post Any Injection  1  61/100 (61.00%)  61 25/49 (51.02%)  25
Respiratory, thoracic and mediastinal disorders     
Cough * 1  6/100 (6.00%)  7 4/50 (8.00%)  4
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
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: NCT01187433     History of Changes
Other Study ID Numbers: CYD30
UTN: U1111-1111-6073 ( Other Identifier: WHO )
First Submitted: August 20, 2010
First Posted: August 24, 2010
Results First Submitted: September 25, 2016
Results First Posted: November 11, 2016
Last Update Posted: November 11, 2016