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Trial record 1 of 1 for:    CYD22
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Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00875524
Recruitment Status : Completed
First Posted : April 3, 2009
Results First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Dengue Virus
Dengue Fever
Dengue Hemorrhagic Fever
Dengue Disease
Interventions Biological: CYD dengue vaccine serotypes (1, 2, 3, 4).
Biological: Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide
Enrollment 180
Recruitment Details Study participants were enrolled from 18 March 2009 to 01 July 2010 at 1 clinical center in Vietnam.
Pre-assignment Details A total of 180 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 Vaccine Group
Hide Arm/Group Description Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injection. Participants were followed for 4 years after the third injection. Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection.
Period Title: Overall Study
Started 120 60
Received Vaccination 1 120 60
Received Vaccination 2 116 58
Received Vaccination 3 114 58
Completed 112 54
Not Completed 8 6
Reason Not Completed
Serious adverse event             0             1
Protocol Violation             4             0
Lost to Follow-up             1             0
Withdrawal by Subject             3             5
Arm/Group Title CYD Dengue Vaccine Group Control Group Total
Hide Arm/Group Description Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants were followed for 4 years after the third injection. Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection. Total of all reporting groups
Overall Number of Baseline Participants 120 60 180
Hide Baseline Analysis Population Description
The safety analysis set was defined as participants who received at least 1 dose of CYD dengue vaccine or control vaccine.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 60 participants 180 participants
10.9  (8.6) 11.8  (9.6) 11.2  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 60 participants 180 participants
Female
62
  51.7%
25
  41.7%
87
  48.3%
Male
58
  48.3%
35
  58.3%
93
  51.7%
1.Primary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine
Hide Description Geometric mean titers against each serotype of the parental dengue virus strains were assessed using the dengue Plaque Reduction Neutralization Test (PRNT).
Time Frame Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Per-protocol analysis (PPA) set which included participants who received at least 1 dose of the study vaccine and had no protocol deviations, randomization error, blood sample not taken within the period and forbidden treatments. Here, 'number analyzed' = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Vaccine Group
Hide Arm/Group Description:
Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants were followed for 4 years after the third injection.
Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection.
Overall Number of Participants Analyzed 119 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dil)
Dengue Parental Serotype 1; Pre-Inj. 1 Number Analyzed 119 participants 60 participants
32.7
(21.6 to 49.5)
19.6
(12 to 31.8)
Dengue Parental Serotype 1; Post-Inj. 1 Number Analyzed 119 participants 60 participants
70.9
(44.3 to 113)
18.8
(11.4 to 30.8)
Dengue Parental Serotype 1; Pre-Inj. 2 Number Analyzed 115 participants 58 participants
52.2
(33.3 to 81.6)
19.8
(11.4 to 34.3)
Dengue Parental Serotype 1; Post-Inj. 2 Number Analyzed 115 participants 58 participants
100
(65.1 to 155)
20.6
(11.8 to 36.0)
Dengue Parental Serotype 1; Pre-Inj. 3 Number Analyzed 114 participants 58 participants
70.9
(45.5 to 110)
24.6
(13.7 to 44.0)
Dengue Parental Serotype 1; Post-Inj. 3 Number Analyzed 114 participants 58 participants
129
(90.5 to 183)
25.3
(13.7 to 46.8)
Dengue Parental Serotype 2; Pre-Inj. 1 Number Analyzed 119 participants 60 participants
33.1
(22.5 to 48.7)
27.2
(15.3 to 48.1)
Dengue Parental Serotype 2; Post-Inj. 1 Number Analyzed 119 participants 59 participants
92.3
(58.5 to 145)
25.0
(13.8 to 45.4)
Dengue Parental Serotype 2; Pre-Inj. 2 Number Analyzed 115 participants 58 participants
74.8
(47.7 to 117)
29.5
(16.0 to 54.4)
Dengue Parental Serotype 2; Post-Inj. 2 Number Analyzed 115 participants 58 participants
195
(139 to 274)
29.3
(16.0 to 53.8)
Dengue Parental Serotype 2; Pre-Inj. 3 Number Analyzed 114 participants 58 participants
111
(74.4 to 165)
32.3
(17.4 to 59.8)
Dengue Parental Serotype 2; Post-Inj. 3 Number Analyzed 114 participants 58 participants
216
(163 to 286)
30.4
(16.7 to 55.1)
Dengue Parental Serotype 3; Pre-Inj. 1 Number Analyzed 119 participants 59 participants
31.9
(23.3 to 43.8)
20.5
(13.2 to 31.9)
Dengue Parental Serotype 3; Post-Inj. 1 Number Analyzed 119 participants 59 participants
95.6
(67.2 to 136)
18.4
(12.0 to 28.2)
Dengue Parental Serotype 3; Pre-Inj. 2 Number Analyzed 115 participants 58 participants
60.4
(41.9 to 87.2)
19.1
(12.1 to 30.3)
Dengue Parental Serotype 3; Post-Inj. 2 Number Analyzed 115 participants 58 participants
152
(115 to 203)
21.9
(14.1 to 34.0)
Dengue Parental Serotype 3; Pre-Inj. 3 Number Analyzed 114 participants 58 participants
87.2
(62.5 to 122)
26.8
(17.1 to 42.1)
Dengue Parental Serotype 3; Post-Inj. 3 Number Analyzed 114 participants 58 participants
169
(134 to 214)
25.2
(16.3 to 39.1)
Dengue Parental Serotype 4; Pre-Inj. 1 Number Analyzed 119 participants 59 participants
17.0
(12.8 to 22.5)
13.9
(9.28 to 20.9)
Dengue Parental Serotype 4; Post-Inj. 1 Number Analyzed 119 participants 60 participants
104
(71.0 to 153)
15.4
(10.2 to 23.3)
Dengue Parental Serotype 4; Pre-Inj. 2 Number Analyzed 115 participants 58 participants
51.7
(37.0 to 72.2)
14.1
(9.29 to 21.4)
Dengue Parental Serotype 4; Post-Inj. 2 Number Analyzed 115 participants 57 participants
120
(89.2 to 160)
14.3
(9.44 to 21.6)
Dengue Parental Serotype 4; Pre-Inj. 3 Number Analyzed 114 participants 58 participants
70.1
(52.2 to 94.1)
17.1
(10.9 to 26.9)
Dengue Parental Serotype 4; Post-Inj. 3 Number Analyzed 114 participants 58 participants
146
(115 to 184)
17.4
(11.2 to 27.0)
2.Primary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
Hide Description GMT against each serotype of the parental dengue virus strains were assessed using the dengue PRNT.
Time Frame Year 1, Year 2, Year 3 and Year 4 after the Third Injection
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set which included all the participants present at first vaccination (V01) and received at least one dose of vaccine. Here, 'number analyzed' = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Vaccine Group
Hide Arm/Group Description:
Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants were followed for 4 years after the third injection.
Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection.
Overall Number of Participants Analyzed 120 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dil)
Dengue Parental Serotype 1: Year 1 Number Analyzed 113 participants 57 participants
103
(69.0 to 152)
28.4
(15.5 to 52.3)
Dengue Parental Serotype 1: Year 2 Number Analyzed 112 participants 57 participants
72.9
(48.9 to 109)
25.7
(14.0 to 47.3)
Dengue Parental Serotype 1: Year 3 Number Analyzed 112 participants 55 participants
56.0
(35.9 to 87.4)
29.7
(15.3 to 57.7)
Dengue Parental Serotype 1: Year 4 Number Analyzed 112 participants 54 participants
52.6
(34.0 to 81.2)
30.5
(15.8 to 58.6)
Dengue Parental Serotype 2: Year 1 Number Analyzed 113 participants 57 participants
133
(91.7 to 192)
36.9
(19.6 to 69.4)
Dengue Parental Serotype 2: Year 2 Number Analyzed 112 participants 57 participants
118
(79.3 to 176)
42.6
(22.1 to 82.0)
Dengue Parental Serotype 2: Year 3 Number Analyzed 112 participants 55 participants
78.1
(52.6 to 116)
45.2
(23.7 to 86.1)
Dengue Parental Serotype 2: Year 4 Number Analyzed 112 participants 54 participants
73.7
(49.3 to 110)
50.7
(26.5 to 97.1)
Dengue Parental Serotype 3: Year 1 Number Analyzed 113 participants 57 participants
145
(104 to 202)
31.8
(18.2 to 55.5)
Dengue Parental Serotype 3: Year 2 Number Analyzed 112 participants 57 participants
88.2
(64.6 to 120)
26.1
(15.7 to 43.7)
Dengue Parental Serotype 3: Year 3 Number Analyzed 112 participants 55 participants
66.6
(47.8 to 92.9)
24.4
(14.9 to 40.1)
Dengue Parental Serotype 3: Year 4 Number Analyzed 112 participants 54 participants
42.7
(31.2 to 58.5)
19.7
(12.5 to 31.1)
Dengue Parental Serotype 4: Year 1 Number Analyzed 113 participants 57 participants
87.5
(67.2 to 114)
19.0
(12.0 to 30.3)
Dengue Parental Serotype 4: Year 2 Number Analyzed 112 participants 57 participants
56.9
(44.9 to 72.1)
17.5
(10.9 to 27.9)
Dengue Parental Serotype 4: Year 3 Number Analyzed 112 participants 55 participants
47.3
(36.9 to 60.5)
21.7
(13.3 to 35.4)
Dengue Parental Serotype 4: Year 4 Number Analyzed 112 participants 54 participants
30.2
(23.9 to 38.3)
18.2
(11.5 to 28.8)
3.Primary Outcome
Title Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine
Hide Description Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.
Time Frame Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPA set. Here, ‘number analyzed’ = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Vaccine Group
Hide Arm/Group Description:
Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants were followed for 4 years after the third injection.
Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection.
Overall Number of Participants Analyzed 119 60
Measure Type: Number
Unit of Measure: Percentage of participants
Dengue Parental Serotype 1; Pre-Inj. 1 Number Analyzed 119 participants 60 participants
50.4 43.3
Dengue Parental Serotype 1; Post-Inj. 1 Number Analyzed 119 participants 60 participants
62.2 41.7
Dengue Parental Serotype 1; Pre-Inj. 2 Number Analyzed 115 participants 58 participants
58.3 39.7
Dengue Parental Serotype 1; Post-Inj. 2 Number Analyzed 115 participants 58 participants
79.1 41.4
Dengue Parental Serotype 1; Pre-Inj. 3 Number Analyzed 114 participants 58 participants
68.4 46.6
Dengue Parental Serotype 1; Post-Inj. 3 Number Analyzed 114 participants 58 participants
93.0 41.4
Dengue Parental Serotype 2; Pre-Inj. 1 Number Analyzed 119 participants 60 participants
49.6 41.7
Dengue Parental Serotype 2; Post-Inj. 1 Number Analyzed 119 participants 59 participants
66.4 35.6
Dengue Parental Serotype 2; Pre-Inj. 2 Number Analyzed 115 participants 58 participants
63.5 39.7
Dengue Parental Serotype 2; Post-Inj. 2 Number Analyzed 115 participants 58 participants
93.9 41.4
Dengue Parental Serotype 2; Pre-Inj. 3 Number Analyzed 114 participants 58 participants
80.7 43.1
Dengue Parental Serotype 2; Post-Inj. 3 Number Analyzed 114 participants 58 participants
99.1 43.1
Dengue Parental Serotype 3; Pre-Inj. 1 Number Analyzed 119 participants 59 participants
63.0 52.5
Dengue Parental Serotype 3; Post-Inj. 1 Number Analyzed 119 participants 59 participants
84.9 47.5
Dengue Parental Serotype 3; Pre-Inj. 2 Number Analyzed 115 participants 58 participants
73.0 46.6
Dengue Parental Serotype 3; Post-Inj. 2 Number Analyzed 115 participants 58 participants
94.8 53.4
Dengue Parental Serotype 3; Pre-Inj. 3 Number Analyzed 114 participants 58 participants
85.1 62.1
Dengue Parental Serotype 3; Post-Inj. 3 Number Analyzed 114 participants 58 participants
99.1 58.6
Dengue Parental Serotype 4; Pre-Inj. 1 Number Analyzed 119 participants 59 participants
44.5 37.3
Dengue Parental Serotype 4; Post-Inj. 1 Number Analyzed 119 participants 60 participants
77.3 41.7
Dengue Parental Serotype 4; Pre-Inj. 2 Number Analyzed 115 participants 58 participants
73.0 39.7
Dengue Parental Serotype 4; Post-Inj. 2 Number Analyzed 115 participants 57 participants
89.6 40.4
Dengue Parental Serotype 4; Pre-Inj. 3 Number Analyzed 114 participants 58 participants
84.2 43.1
Dengue Parental Serotype 4; Post-Inj. 3 Number Analyzed 114 participants 58 participants
95.6 43.1
4.Primary Outcome
Title Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period
Hide Description Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.
Time Frame Year 1, Year 2, Year 3 and Year 4 after the Third Injection
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Vaccine Group
Hide Arm/Group Description:
Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants were followed for 4 years after the third injection.
Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection.
Overall Number of Participants Analyzed 120 60
Measure Type: Number
Unit of Measure: Percentage of participants
Dengue Parental Serotype 1: Year 1 Number Analyzed 113 participants 57 participants
78.8 43.9
Dengue Parental Serotype 1: Year 2 Number Analyzed 112 participants 57 participants
74.1 38.6
Dengue Parental Serotype 1: Year 3 Number Analyzed 112 participants 55 participants
59.8 40.0
Dengue Parental Serotype 1: Year 4 Number Analyzed 112 participants 54 participants
61.6 40.7
Dengue Parental Serotype 2: Year 1 Number Analyzed 113 participants 57 participants
86.7 47.4
Dengue Parental Serotype 2: Year 2 Number Analyzed 112 participants 57 participants
82.1 49.1
Dengue Parental Serotype 2: Year 3 Number Analyzed 112 participants 55 participants
70.5 50.9
Dengue Parental Serotype 2: Year 4 Number Analyzed 112 participants 54 participants
68.8 53.7
Dengue Parental Serotype 3: Year 1 Number Analyzed 113 participants 57 participants
92.9 54.4
Dengue Parental Serotype 3: Year 2 Number Analyzed 112 participants 57 participants
86.6 54.4
Dengue Parental Serotype 3: Year 3 Number Analyzed 112 participants 55 participants
75.0 54.5
Dengue Parental Serotype 3: Year 4 Number Analyzed 112 participants 54 participants
70.5 44.4
Dengue Parental Serotype 4: Year 1 Number Analyzed 113 participants 57 participants
88.5 47.4
Dengue Parental Serotype 4: Year 2 Number Analyzed 112 participants 57 participants
90.2 40.4
Dengue Parental Serotype 4: Year 3 Number Analyzed 112 participants 55 participants
87.5 47.3
Dengue Parental Serotype 4: Year 4 Number Analyzed 112 participants 54 participants
76.8 42.6
5.Primary Outcome
Title Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Hide Description Solicited Inj. site reactions: Pain, Erythema, and Swelling. Pain:- Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: Incapacitating, unable to perform usual activities. Erythema and Swelling:- Grade 1: <2.5 cm, Grade 2: >=2.5 to <5 cm, Grade 3: >= 5 cm.
Time Frame 7 days post-each injection
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety analysis set. Here, 'number analyzed' = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Vaccine Group
Hide Arm/Group Description:
Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants were followed for 4 years after the third injection.
Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection.
Overall Number of Participants Analyzed 120 60
Measure Type: Number
Unit of Measure: Percentage of participants
Inj. site Pain; Post-Any Inj. Number Analyzed 120 participants 60 participants
28.3 80
Grade 3 Inj. site Pain; Post-Any Inj. Number Analyzed 120 participants 60 participants
0.0 0.0
Inj. site Erythema; Post-Any Inj. Number Analyzed 120 participants 60 participants
6.7 21.7
Grade 3 Inj. site Erythema; Post-Any Inj. Number Analyzed 120 participants 60 participants
0.0 1.7
Inj. site Swelling; Post-Any Inj. Number Analyzed 119 participants 60 participants
4.2 15.0
Grade 3 Inj. site Swelling; Post-Any Inj. Number Analyzed 119 participants 60 participants
0.0 1.7
Inj. site Pain; Post-Inj. 1 Number Analyzed 120 participants 60 participants
15.8 73.3
Grade 3 Inj. site Pain; Post-Inj. 1 Number Analyzed 120 participants 60 participants
0.0 0.0
Inj. site Erythema; Post-Inj. 1 Number Analyzed 120 participants 60 participants
4.2 16.7
Grade 3 Inj. site Erythema; Post-Inj. 1 Number Analyzed 120 participants 60 participants
0.0 1.7
Inj. site Swelling; Post-Inj. 1 Number Analyzed 119 participants 60 participants
1.7 6.7
Grade 3 Inj. site Swelling; Post-Inj. 1 Number Analyzed 119 participants 60 participants
0.0 1.7
Inj. site Pain; Post-Inj. 2 Number Analyzed 116 participants 58 participants
15.5 15.5
Grade 3 Inj. site Pain; Post-Inj. 2 Number Analyzed 116 participants 58 participants
0.0 0.0
Inj. site Erythema; Post-Inj. 2 Number Analyzed 116 participants 58 participants
4.3 5.2
Grade 3 Inj. site Erythema; Post-Inj. 2 Number Analyzed 116 participants 58 participants
0.0 0.0
Inj. site Swelling; Post-Inj. 2 Number Analyzed 116 participants 58 participants
2.6 3.4
Grade 3 Inj. site Swelling; Post-Inj. 2 Number Analyzed 116 participants 58 participants
0.0 0.0
Inj. site Pain; Post-Inj. 3 Number Analyzed 114 participants 58 participants
11.4 41.4
Grade 3 Inj. site Pain; Post-Inj. 3 Number Analyzed 114 participants 58 participants
0.0 0.0
Inj. site Erythema; Post-Inj. 3 Number Analyzed 114 participants 58 participants
2.6 5.2
Grade 3 Inj. site Erythema; Post-Inj. 3 Number Analyzed 114 participants 58 participants
0.0 0.0
Inj. site Swelling; Post-Inj. 3 Number Analyzed 114 participants 58 participants
0.0 6.9
Grade 3 Inj. site Swelling; Post-Inj. 3 Number Analyzed 114 participants 58 participants
0.0 0.0
6.Primary Outcome
Title Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Hide Description Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever:- Grade 1: >=37.5 degree Celsius (°C) to <=38.0°C, Grade 2: >38.0°C to <=39.0°C, Grade 3: >39.0°C. Headache, malaise, myalgia and asthenia: Grade 1: noticeable but does not interfere with daily activities, Grade 2: interferes with daily activities, Grade 3: prevents daily activities.
Time Frame 14 days post-each injection
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety analysis set. Here, 'number analyzed' = participants with available data for each specified category.
Arm/Group Title CYD Dengue Vaccine Group Control Vaccine Group
Hide Arm/Group Description:
Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants were followed for 4 years after the third injection.
Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection.
Overall Number of Participants Analyzed 120 60
Measure Type: Number
Unit of Measure: Percentage of participants
Fever; Post-Any Inj. Number Analyzed 120 participants 60 participants
27.5 26.7
Grade 3 Fever; Post-Any Inj. Number Analyzed 120 participants 60 participants
0.8 3.3
Headache; Post-Any Inj. Number Analyzed 119 participants 60 participants
35.3 30.0
Grade 3 Headache; Post-Any Inj. Number Analyzed 119 participants 60 participants
0.8 0.0
Malaise; Post-Any Inj. Number Analyzed 119 participants 60 participants
29.4 23.3
Grade 3 Malaise; Post-Any Inj. Number Analyzed 119 participants 60 participants
0.0 0.0
Myalgia; Post-Any Inj. Number Analyzed 119 participants 60 participants
20.2 23.3
Grade 3 Myalgia; Post-Any Inj. Number Analyzed 119 participants 60 participants
0.0 0.0
Asthenia; Post-Any Inj. Number Analyzed 119 participants 60 participants
13.4 5.0
Grade 3 Asthenia; Post-Any Inj. Number Analyzed 119 participants 60 participants
1.7 0.0
Fever; Post-Inj. 1 Number Analyzed 120 participants 60 participants
19.2 15.0
Grade 3 Fever; Post-Inj. 1 Number Analyzed 120 participants 60 participants
0.8 3.3
Headache; Post-Inj. 1 Number Analyzed 119 participants 60 participants
29.4 28.3
Grade 3 Headache; Post-Inj. 1 Number Analyzed 119 participants 60 participants
0.8 0.0
Malaise; Post-Inj. 1 Number Analyzed 119 participants 60 participants
21.8 16.7
Grade 3 Malaise; Post-Inj. 1 Number Analyzed 119 participants 60 participants
0.0 0.0
Myalgia; Post-Inj. 1 Number Analyzed 119 participants 60 participants
15.1 20.0
Grade 3 Myalgia; Post-Inj. 1 Number Analyzed 119 participants 60 participants
0.0 0.0
Asthenia; Post-Inj. 1 Number Analyzed 119 participants 60 participants
8.4 0.0
Grade 3 Asthenia; Post-Inj. 1 Number Analyzed 119 participants 60 participants
0.8 0.0
Fever; Post-Inj. 2 Number Analyzed 116 participants 58 participants
12.1 6.9
Grade 3 Fever; Post-Inj. 2 Number Analyzed 116 participants 58 participants
0.0 0.0
Headache; Post-Inj. 2 Number Analyzed 115 participants 58 participants
15.7 8.6
Grade 3 Headache; Post-Inj. 2 Number Analyzed 115 participants 58 participants
0.0 0.0
Malaise; Post-Inj. 2 Number Analyzed 115 participants 58 participants
13.0 8.6
Grade 3 Malaise; Post-Inj. 2 Number Analyzed 115 participants 58 participants
0.0 0.0
Myalgia; Post-Inj. 2 Number Analyzed 115 participants 58 participants
9.6 5.2
Grade 3 Myalgia; Post-Inj. 2 Number Analyzed 115 participants 58 participants
0.0 0.0
Asthenia; Post-Inj. 2 Number Analyzed 115 participants 58 participants
6.1 1.7
Grade 3 Asthenia; Post-Inj. 2 Number Analyzed 115 participants 58 participants
0.9 0.0
Fever; Post-Inj. 3 Number Analyzed 114 participants 58 participants
3.5 8.6
Grade 3 Fever; Post-Inj. 3 Number Analyzed 114 participants 58 participants
0.0 0.0
Headache; Post-Inj. 3 Number Analyzed 114 participants 58 participants
8.8 10.3
Grade 3 Headache; Post-Inj. 3 Number Analyzed 114 participants 58 participants
0.0 0.0
Malaise; Post-Inj. 3 Number Analyzed 114 participants 58 participants
5.3 8.6
Grade 3 Malaise; Post-Inj. 3 Number Analyzed 114 participants 58 participants
0.0 0.0
Myalgia; Post-Inj. 3 Number Analyzed 114 participants 58 participants
4.4 10.3
Grade 3 Myalgia; Post-Inj. 3 Number Analyzed 114 participants 58 participants
0.0 0.0
Asthenia; Post-Inj. 3 Number Analyzed 114 participants 58 participants
0.9 3.4
Grade 3 Asthenia; Post-Inj. 3 Number Analyzed 114 participants 58 participants
0.0 0.0
Time Frame Serious Adverse Events (SAEs) data were collected throughout the study from Day 0 to Year 4, and non-serious Adverse Events were collected for 28 days after each injection.
Adverse Event Reporting Description Non-related SAEs were collected from Day 0 (post-injection) up to 6 months after the last injection. Related and fatal SAEs were reported from 6 months until the end of study (up to 4 years).
 
Arm/Group Title CYD Dengue Vaccine Group Control Vaccine Group
Hide Arm/Group Description Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants were followed for 4 years after the third injection. Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection.
All-Cause Mortality
CYD Dengue Vaccine Group Control Vaccine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/120 (0.00%)      0/60 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
CYD Dengue Vaccine Group Control Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/120 (2.50%)      3/60 (5.00%)    
Gastrointestinal disorders     
Gastritis * 1  1/120 (0.83%)  1 0/60 (0.00%)  0
Infections and infestations     
Dengue fever * 1  1/120 (0.83%)  1 3/60 (5.00%)  3
Pharyngitis * 1  1/120 (0.83%)  1 0/60 (0.00%)  0
1
Term from vocabulary, MedDRA 11.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CYD Dengue Vaccine Group Control Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/120 (35.00%)      48/60 (80.00%)    
General disorders     
Injection site Pain; Post-Any  1  34/120 (28.33%)  50 48/60 (80.00%)  77
Injection site Erythema; Post-Any  1  8/120 (6.67%)  13 13/60 (21.67%)  16
Injection site Swelling; Post-Any  1  5/119 (4.20%)  5 9/60 (15.00%)  10
Fever; Post-Any Injection  1  33/120 (27.50%)  41 16/60 (26.67%)  18
Malaise; Post-Any Injection  1  35/119 (29.41%)  47 14/60 (23.33%)  20
Asthenia; Post-Any Injection  1  16/119 (13.45%)  18 3/60 (5.00%)  3
Infections and infestations     
Nasopharyngitis * 1  0/120 (0.00%)  0 3/60 (5.00%)  3
Pharyngitis * 1  9/120 (7.50%)  9 7/60 (11.67%)  7
Musculoskeletal and connective tissue disorders     
Myalgia; Post-Any Injection  1  24/119 (20.17%)  34 14/60 (23.33%)  21
Nervous system disorders     
Headache; Post-Any Injection  1  42/119 (35.29%)  63 18/60 (30.00%)  28
1
Term from vocabulary, MedDRA 11.0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur SA
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00875524     History of Changes
Other Study ID Numbers: CYD22
2014-001709-41 ( EudraCT Number )
First Submitted: April 2, 2009
First Posted: April 3, 2009
Results First Submitted: May 21, 2019
Results First Posted: July 24, 2019
Last Update Posted: July 24, 2019