Trial Outcomes & Findings for Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects (NCT NCT00875524)
NCT ID: NCT00875524
Last Updated: 2022-04-05
Results Overview
Geometric mean titers against each serotype of the parental dengue virus strains were assessed using the dengue Plaque Reduction Neutralization Test (PRNT).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
180 participants
Primary outcome timeframe
Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3
Results posted on
2022-04-05
Participant Flow
Study participants were enrolled from 18 March 2009 to 01 July 2010 at 1 clinical center in Vietnam.
A total of 180 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized.
Participant milestones
| Measure |
CYD Dengue Vaccine Group
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.
|
Control Vaccine Group
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 Study
STARTED
|
120
|
60
|
|
Overall Study
Received Vaccination 1
|
120
|
60
|
|
Overall Study
Received Vaccination 2
|
116
|
58
|
|
Overall Study
Received Vaccination 3
|
114
|
58
|
|
Overall Study
COMPLETED
|
112
|
54
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
CYD Dengue Vaccine Group
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.
|
Control Vaccine Group
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 Study
Serious adverse event
|
0
|
1
|
|
Overall Study
Protocol Violation
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
Baseline Characteristics
Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects
Baseline characteristics by cohort
| Measure |
CYD Dengue Vaccine Group
n=120 Participants
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.
|
Control Group
n=60 Participants
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
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.9 Years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
11.8 Years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
11.2 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3Population: 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.
Geometric mean titers against each serotype of the parental dengue virus strains were assessed using the dengue Plaque Reduction Neutralization Test (PRNT).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=119 Participants
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.
|
Control Vaccine Group
n=60 Participants
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.
|
|---|---|---|
|
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
Dengue Parental Serotype 2; Post-Inj. 1
|
92.3 Titers (1/dil)
Interval 58.5 to 145.0
|
25.0 Titers (1/dil)
Interval 13.8 to 45.4
|
|
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
Dengue Parental Serotype 2; Pre-Inj. 2
|
74.8 Titers (1/dil)
Interval 47.7 to 117.0
|
29.5 Titers (1/dil)
Interval 16.0 to 54.4
|
|
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
Dengue Parental Serotype 4; Pre-Inj. 2
|
51.7 Titers (1/dil)
Interval 37.0 to 72.2
|
14.1 Titers (1/dil)
Interval 9.29 to 21.4
|
|
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
Dengue Parental Serotype 1; Pre-Inj. 1
|
32.7 Titers (1/dil)
Interval 21.6 to 49.5
|
19.6 Titers (1/dil)
Interval 12.0 to 31.8
|
|
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
Dengue Parental Serotype 1; Post-Inj. 1
|
70.9 Titers (1/dil)
Interval 44.3 to 113.0
|
18.8 Titers (1/dil)
Interval 11.4 to 30.8
|
|
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
Dengue Parental Serotype 1; Pre-Inj. 2
|
52.2 Titers (1/dil)
Interval 33.3 to 81.6
|
19.8 Titers (1/dil)
Interval 11.4 to 34.3
|
|
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
Dengue Parental Serotype 1; Post-Inj. 2
|
100 Titers (1/dil)
Interval 65.1 to 155.0
|
20.6 Titers (1/dil)
Interval 11.8 to 36.0
|
|
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
Dengue Parental Serotype 1; Pre-Inj. 3
|
70.9 Titers (1/dil)
Interval 45.5 to 110.0
|
24.6 Titers (1/dil)
Interval 13.7 to 44.0
|
|
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
Dengue Parental Serotype 1; Post-Inj. 3
|
129 Titers (1/dil)
Interval 90.5 to 183.0
|
25.3 Titers (1/dil)
Interval 13.7 to 46.8
|
|
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
Dengue Parental Serotype 2; Pre-Inj. 1
|
33.1 Titers (1/dil)
Interval 22.5 to 48.7
|
27.2 Titers (1/dil)
Interval 15.3 to 48.1
|
|
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
Dengue Parental Serotype 2; Post-Inj. 2
|
195 Titers (1/dil)
Interval 139.0 to 274.0
|
29.3 Titers (1/dil)
Interval 16.0 to 53.8
|
|
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
Dengue Parental Serotype 2; Pre-Inj. 3
|
111 Titers (1/dil)
Interval 74.4 to 165.0
|
32.3 Titers (1/dil)
Interval 17.4 to 59.8
|
|
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
Dengue Parental Serotype 2; Post-Inj. 3
|
216 Titers (1/dil)
Interval 163.0 to 286.0
|
30.4 Titers (1/dil)
Interval 16.7 to 55.1
|
|
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
Dengue Parental Serotype 3; Pre-Inj. 1
|
31.9 Titers (1/dil)
Interval 23.3 to 43.8
|
20.5 Titers (1/dil)
Interval 13.2 to 31.9
|
|
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
Dengue Parental Serotype 3; Post-Inj. 1
|
95.6 Titers (1/dil)
Interval 67.2 to 136.0
|
18.4 Titers (1/dil)
Interval 12.0 to 28.2
|
|
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
Dengue Parental Serotype 3; Pre-Inj. 2
|
60.4 Titers (1/dil)
Interval 41.9 to 87.2
|
19.1 Titers (1/dil)
Interval 12.1 to 30.3
|
|
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
Dengue Parental Serotype 3; Post-Inj. 2
|
152 Titers (1/dil)
Interval 115.0 to 203.0
|
21.9 Titers (1/dil)
Interval 14.1 to 34.0
|
|
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
Dengue Parental Serotype 3; Pre-Inj. 3
|
87.2 Titers (1/dil)
Interval 62.5 to 122.0
|
26.8 Titers (1/dil)
Interval 17.1 to 42.1
|
|
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
Dengue Parental Serotype 3; Post-Inj. 3
|
169 Titers (1/dil)
Interval 134.0 to 214.0
|
25.2 Titers (1/dil)
Interval 16.3 to 39.1
|
|
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
Dengue Parental Serotype 4; Pre-Inj. 1
|
17.0 Titers (1/dil)
Interval 12.8 to 22.5
|
13.9 Titers (1/dil)
Interval 9.28 to 20.9
|
|
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
Dengue Parental Serotype 4; Post-Inj. 1
|
104 Titers (1/dil)
Interval 71.0 to 153.0
|
15.4 Titers (1/dil)
Interval 10.2 to 23.3
|
|
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
Dengue Parental Serotype 4; Post-Inj. 2
|
120 Titers (1/dil)
Interval 89.2 to 160.0
|
14.3 Titers (1/dil)
Interval 9.44 to 21.6
|
|
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
Dengue Parental Serotype 4; Pre-Inj. 3
|
70.1 Titers (1/dil)
Interval 52.2 to 94.1
|
17.1 Titers (1/dil)
Interval 10.9 to 26.9
|
|
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
Dengue Parental Serotype 4; Post-Inj. 3
|
146 Titers (1/dil)
Interval 115.0 to 184.0
|
17.4 Titers (1/dil)
Interval 11.2 to 27.0
|
PRIMARY outcome
Timeframe: Year 1, Year 2, Year 3 and Year 4 after the Third InjectionPopulation: 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.
GMT against each serotype of the parental dengue virus strains were assessed using the dengue PRNT.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=120 Participants
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.
|
Control Vaccine Group
n=60 Participants
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.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
Dengue Parental Serotype 3: Year 2
|
88.2 Titers (1/dil)
Interval 64.6 to 120.0
|
26.1 Titers (1/dil)
Interval 15.7 to 43.7
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
Dengue Parental Serotype 3: Year 3
|
66.6 Titers (1/dil)
Interval 47.8 to 92.9
|
24.4 Titers (1/dil)
Interval 14.9 to 40.1
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
Dengue Parental Serotype 1: Year 1
|
103 Titers (1/dil)
Interval 69.0 to 152.0
|
28.4 Titers (1/dil)
Interval 15.5 to 52.3
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
Dengue Parental Serotype 1: Year 2
|
72.9 Titers (1/dil)
Interval 48.9 to 109.0
|
25.7 Titers (1/dil)
Interval 14.0 to 47.3
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
Dengue Parental Serotype 1: Year 3
|
56.0 Titers (1/dil)
Interval 35.9 to 87.4
|
29.7 Titers (1/dil)
Interval 15.3 to 57.7
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
Dengue Parental Serotype 1: Year 4
|
52.6 Titers (1/dil)
Interval 34.0 to 81.2
|
30.5 Titers (1/dil)
Interval 15.8 to 58.6
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
Dengue Parental Serotype 2: Year 1
|
133 Titers (1/dil)
Interval 91.7 to 192.0
|
36.9 Titers (1/dil)
Interval 19.6 to 69.4
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
Dengue Parental Serotype 2: Year 2
|
118 Titers (1/dil)
Interval 79.3 to 176.0
|
42.6 Titers (1/dil)
Interval 22.1 to 82.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
Dengue Parental Serotype 2: Year 3
|
78.1 Titers (1/dil)
Interval 52.6 to 116.0
|
45.2 Titers (1/dil)
Interval 23.7 to 86.1
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
Dengue Parental Serotype 2: Year 4
|
73.7 Titers (1/dil)
Interval 49.3 to 110.0
|
50.7 Titers (1/dil)
Interval 26.5 to 97.1
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
Dengue Parental Serotype 3: Year 1
|
145 Titers (1/dil)
Interval 104.0 to 202.0
|
31.8 Titers (1/dil)
Interval 18.2 to 55.5
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
Dengue Parental Serotype 3: Year 4
|
42.7 Titers (1/dil)
Interval 31.2 to 58.5
|
19.7 Titers (1/dil)
Interval 12.5 to 31.1
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
Dengue Parental Serotype 4: Year 1
|
87.5 Titers (1/dil)
Interval 67.2 to 114.0
|
19.0 Titers (1/dil)
Interval 12.0 to 30.3
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
Dengue Parental Serotype 4: Year 2
|
56.9 Titers (1/dil)
Interval 44.9 to 72.1
|
17.5 Titers (1/dil)
Interval 10.9 to 27.9
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
Dengue Parental Serotype 4: Year 3
|
47.3 Titers (1/dil)
Interval 36.9 to 60.5
|
21.7 Titers (1/dil)
Interval 13.3 to 35.4
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
Dengue Parental Serotype 4: Year 4
|
30.2 Titers (1/dil)
Interval 23.9 to 38.3
|
18.2 Titers (1/dil)
Interval 11.5 to 28.8
|
PRIMARY outcome
Timeframe: Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3Population: Analysis was performed on PPA set. Here, 'number analyzed' = participants with available data for each specified category.
Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=119 Participants
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.
|
Control Vaccine Group
n=60 Participants
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.
|
|---|---|---|
|
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
Dengue Parental Serotype 2; Pre-Inj. 1
|
49.6 Percentage of participants
|
41.7 Percentage of participants
|
|
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
Dengue Parental Serotype 2; Post-Inj. 1
|
66.4 Percentage of participants
|
35.6 Percentage of participants
|
|
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
Dengue Parental Serotype 3; Post-Inj. 1
|
84.9 Percentage of participants
|
47.5 Percentage of participants
|
|
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
Dengue Parental Serotype 3; Post-Inj. 3
|
99.1 Percentage of participants
|
58.6 Percentage of participants
|
|
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
Dengue Parental Serotype 4; Pre-Inj. 2
|
73.0 Percentage of participants
|
39.7 Percentage of participants
|
|
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
Dengue Parental Serotype 4; Post-Inj. 2
|
89.6 Percentage of participants
|
40.4 Percentage of participants
|
|
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
Dengue Parental Serotype 4; Pre-Inj. 3
|
84.2 Percentage of participants
|
43.1 Percentage of participants
|
|
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
Dengue Parental Serotype 1; Pre-Inj. 1
|
50.4 Percentage of participants
|
43.3 Percentage of participants
|
|
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
Dengue Parental Serotype 1; Post-Inj. 1
|
62.2 Percentage of participants
|
41.7 Percentage of participants
|
|
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
Dengue Parental Serotype 1; Pre-Inj. 2
|
58.3 Percentage of participants
|
39.7 Percentage of participants
|
|
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
Dengue Parental Serotype 1; Post-Inj. 2
|
79.1 Percentage of participants
|
41.4 Percentage of participants
|
|
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
Dengue Parental Serotype 1; Pre-Inj. 3
|
68.4 Percentage of participants
|
46.6 Percentage of participants
|
|
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
Dengue Parental Serotype 1; Post-Inj. 3
|
93.0 Percentage of participants
|
41.4 Percentage of participants
|
|
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
Dengue Parental Serotype 2; Pre-Inj. 2
|
63.5 Percentage of participants
|
39.7 Percentage of participants
|
|
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
Dengue Parental Serotype 2; Post-Inj. 2
|
93.9 Percentage of participants
|
41.4 Percentage of participants
|
|
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
Dengue Parental Serotype 2; Pre-Inj. 3
|
80.7 Percentage of participants
|
43.1 Percentage of participants
|
|
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
Dengue Parental Serotype 2; Post-Inj. 3
|
99.1 Percentage of participants
|
43.1 Percentage of participants
|
|
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
Dengue Parental Serotype 3; Pre-Inj. 1
|
63.0 Percentage of participants
|
52.5 Percentage of participants
|
|
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
Dengue Parental Serotype 3; Pre-Inj. 2
|
73.0 Percentage of participants
|
46.6 Percentage of participants
|
|
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
Dengue Parental Serotype 3; Post-Inj. 2
|
94.8 Percentage of participants
|
53.4 Percentage of participants
|
|
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
Dengue Parental Serotype 3; Pre-Inj. 3
|
85.1 Percentage of participants
|
62.1 Percentage of participants
|
|
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
Dengue Parental Serotype 4; Pre-Inj. 1
|
44.5 Percentage of participants
|
37.3 Percentage of participants
|
|
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
Dengue Parental Serotype 4; Post-Inj. 1
|
77.3 Percentage of participants
|
41.7 Percentage of participants
|
|
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
Dengue Parental Serotype 4; Post-Inj. 3
|
95.6 Percentage of participants
|
43.1 Percentage of participants
|
PRIMARY outcome
Timeframe: Year 1, Year 2, Year 3 and Year 4 after the Third InjectionPopulation: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for each specified category.
Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=120 Participants
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.
|
Control Vaccine Group
n=60 Participants
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.
|
|---|---|---|
|
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
Dengue Parental Serotype 1: Year 2
|
74.1 Percentage of participants
|
38.6 Percentage of participants
|
|
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
Dengue Parental Serotype 1: Year 3
|
59.8 Percentage of participants
|
40.0 Percentage of participants
|
|
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
Dengue Parental Serotype 1: Year 4
|
61.6 Percentage of participants
|
40.7 Percentage of participants
|
|
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
Dengue Parental Serotype 2: Year 1
|
86.7 Percentage of participants
|
47.4 Percentage of participants
|
|
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
Dengue Parental Serotype 2: Year 3
|
70.5 Percentage of participants
|
50.9 Percentage of participants
|
|
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
Dengue Parental Serotype 2: Year 2
|
82.1 Percentage of participants
|
49.1 Percentage of participants
|
|
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
Dengue Parental Serotype 2: Year 4
|
68.8 Percentage of participants
|
53.7 Percentage of participants
|
|
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
Dengue Parental Serotype 1: Year 1
|
78.8 Percentage of participants
|
43.9 Percentage of participants
|
|
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
Dengue Parental Serotype 3: Year 1
|
92.9 Percentage of participants
|
54.4 Percentage of participants
|
|
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
Dengue Parental Serotype 3: Year 2
|
86.6 Percentage of participants
|
54.4 Percentage of participants
|
|
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
Dengue Parental Serotype 3: Year 3
|
75.0 Percentage of participants
|
54.5 Percentage of participants
|
|
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
Dengue Parental Serotype 3: Year 4
|
70.5 Percentage of participants
|
44.4 Percentage of participants
|
|
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
Dengue Parental Serotype 4: Year 1
|
88.5 Percentage of participants
|
47.4 Percentage of participants
|
|
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
Dengue Parental Serotype 4: Year 2
|
90.2 Percentage of participants
|
40.4 Percentage of participants
|
|
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
Dengue Parental Serotype 4: Year 3
|
87.5 Percentage of participants
|
47.3 Percentage of participants
|
|
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
Dengue Parental Serotype 4: Year 4
|
76.8 Percentage of participants
|
42.6 Percentage of participants
|
PRIMARY outcome
Timeframe: 7 days post-each injectionPopulation: Analysis was performed on Safety analysis set. Here, 'number analyzed' = participants with available data for each specified category.
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.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=120 Participants
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.
|
Control Vaccine Group
n=60 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Inj. site Pain; Post-Any Inj.
|
28.3 Percentage of participants
|
80 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Inj. site Erythema; Post-Any Inj.
|
6.7 Percentage of participants
|
21.7 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Inj. site Erythema; Post-Any Inj.
|
0.0 Percentage of participants
|
1.7 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Inj. site Swelling; Post-Any Inj.
|
4.2 Percentage of participants
|
15.0 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Inj. site Pain; Post-Inj. 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Inj. site Erythema; Post-Inj. 1
|
4.2 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Inj. site Erythema; Post-Inj. 1
|
0.0 Percentage of participants
|
1.7 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Inj. site Swelling; Post-Inj. 1
|
1.7 Percentage of participants
|
6.7 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Inj. site Erythema; Post-Inj. 2
|
4.3 Percentage of participants
|
5.2 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Inj. site Erythema; Post-Inj. 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Inj. site Swelling; Post-Inj. 2
|
2.6 Percentage of participants
|
3.4 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Inj. site Swelling; Post-Inj. 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Inj. site Pain; Post-Inj. 3
|
11.4 Percentage of participants
|
41.4 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Inj. site Pain; Post-Inj. 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Inj. site Erythema; Post-Inj. 3
|
2.6 Percentage of participants
|
5.2 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Inj. site Erythema; Post-Inj. 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Inj. site Swelling; Post-Inj. 3
|
0.0 Percentage of participants
|
6.9 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Inj. site Swelling; Post-Inj. 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Inj. site Pain; Post-Any Inj.
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Inj. site Swelling; Post-Any Inj.
|
0.0 Percentage of participants
|
1.7 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Inj. site Pain; Post-Inj. 1
|
15.8 Percentage of participants
|
73.3 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Inj. site Swelling; Post-Inj. 1
|
0.0 Percentage of participants
|
1.7 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Inj. site Pain; Post-Inj. 2
|
15.5 Percentage of participants
|
15.5 Percentage of participants
|
|
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Inj. site Pain; Post-Inj. 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: 14 days post-each injectionPopulation: Analysis was performed on Safety analysis set. Here, 'number analyzed' = participants with available data for each specified category.
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.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=120 Participants
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.
|
Control Vaccine Group
n=60 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Fever; Post-Any Inj.
|
27.5 Percentage of participants
|
26.7 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Fever; Post-Any Inj.
|
0.8 Percentage of participants
|
3.3 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Myalgia; Post-Any Inj.
|
20.2 Percentage of participants
|
23.3 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Myalgia; Post-Any Inj.
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Asthenia; Post-Any Inj.
|
13.4 Percentage of participants
|
5.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Asthenia; Post-Any Inj.
|
1.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Malaise; Post-Inj. 1
|
21.8 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Malaise; Post-Inj. 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Myalgia; Post-Inj. 1
|
15.1 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Myalgia; Post-Inj. 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Headache; Post-Inj. 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Malaise; Post-Inj. 2
|
13.0 Percentage of participants
|
8.6 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Malaise; Post-Inj. 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Myalgia; Post-Inj. 2
|
9.6 Percentage of participants
|
5.2 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Malaise; Post-Inj. 3
|
5.3 Percentage of participants
|
8.6 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Malaise; Post-Inj. 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Myalgia; Post-Inj. 3
|
4.4 Percentage of participants
|
10.3 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Myalgia; Post-Inj. 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Asthenia; Post-Inj. 3
|
0.9 Percentage of participants
|
3.4 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Headache; Post-Any Inj.
|
35.3 Percentage of participants
|
30.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Headache; Post-Any Inj.
|
0.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Malaise; Post-Any Inj.
|
29.4 Percentage of participants
|
23.3 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Malaise; Post-Any Inj.
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Fever; Post-Inj. 1
|
19.2 Percentage of participants
|
15.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Fever; Post-Inj. 1
|
0.8 Percentage of participants
|
3.3 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Headache; Post-Inj. 1
|
29.4 Percentage of participants
|
28.3 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Headache; Post-Inj. 1
|
0.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Asthenia; Post-Inj. 1
|
8.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Asthenia; Post-Inj. 1
|
0.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Fever; Post-Inj. 2
|
12.1 Percentage of participants
|
6.9 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Fever; Post-Inj. 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Headache; Post-Inj. 2
|
15.7 Percentage of participants
|
8.6 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Myalgia; Post-Inj. 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Asthenia; Post-Inj. 2
|
6.1 Percentage of participants
|
1.7 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Asthenia; Post-Inj. 2
|
0.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Fever; Post-Inj. 3
|
3.5 Percentage of participants
|
8.6 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Fever; Post-Inj. 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Headache; Post-Inj. 3
|
8.8 Percentage of participants
|
10.3 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Headache; Post-Inj. 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Grade 3 Asthenia; Post-Inj. 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
Adverse Events
CYD Dengue Vaccine Group
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Control Vaccine Group
Serious events: 3 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CYD Dengue Vaccine Group
n=120 participants at risk
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.
|
Control Vaccine Group
n=60 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.83%
1/120 • Number of events 1 • 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.
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).
|
0.00%
0/60 • 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.
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).
|
|
Infections and infestations
Dengue fever
|
0.83%
1/120 • Number of events 1 • 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.
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).
|
5.0%
3/60 • Number of events 3 • 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.
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).
|
|
Infections and infestations
Pharyngitis
|
0.83%
1/120 • Number of events 1 • 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.
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).
|
0.00%
0/60 • 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.
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).
|
Other adverse events
| Measure |
CYD Dengue Vaccine Group
n=120 participants at risk
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.
|
Control Vaccine Group
n=60 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Headache; Post-Any Injection
|
35.3%
42/119 • Number of events 63 • 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.
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).
|
30.0%
18/60 • Number of events 28 • 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.
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).
|
|
General disorders
Injection site Pain; Post-Any
|
28.3%
34/120 • Number of events 50 • 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.
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).
|
80.0%
48/60 • Number of events 77 • 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.
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).
|
|
General disorders
Injection site Erythema; Post-Any
|
6.7%
8/120 • Number of events 13 • 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.
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).
|
21.7%
13/60 • Number of events 16 • 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.
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).
|
|
General disorders
Injection site Swelling; Post-Any
|
4.2%
5/119 • Number of events 5 • 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.
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).
|
15.0%
9/60 • Number of events 10 • 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.
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).
|
|
General disorders
Fever; Post-Any Injection
|
27.5%
33/120 • Number of events 41 • 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.
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).
|
26.7%
16/60 • Number of events 18 • 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.
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).
|
|
General disorders
Malaise; Post-Any Injection
|
29.4%
35/119 • Number of events 47 • 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.
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).
|
23.3%
14/60 • Number of events 20 • 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.
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).
|
|
General disorders
Asthenia; Post-Any Injection
|
13.4%
16/119 • Number of events 18 • 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.
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).
|
5.0%
3/60 • Number of events 3 • 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.
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).
|
|
Musculoskeletal and connective tissue disorders
Myalgia; Post-Any Injection
|
20.2%
24/119 • Number of events 34 • 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.
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).
|
23.3%
14/60 • Number of events 21 • 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.
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).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/120 • 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.
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).
|
5.0%
3/60 • Number of events 3 • 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.
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).
|
|
Infections and infestations
Pharyngitis
|
7.5%
9/120 • Number of events 9 • 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.
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).
|
11.7%
7/60 • Number of events 7 • 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.
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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER