Trial Outcomes & Findings for Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years (NCT NCT00788151)
NCT ID: NCT00788151
Last Updated: 2022-04-05
Results Overview
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
300 participants
Primary outcome timeframe
Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Results posted on
2022-04-05
Participant Flow
Study participants were enrolled from 26 September 2008 to 16 August 2010 at 1 clinical site in Peru.
A total of 300 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized in the study. Two participants were not vaccinated and were excluded from the Full analysis set and Safety analysis set.
Participant milestones
| Measure |
CYD Dengue Vaccine Group
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
Participants received two injections of placebo, and 1 injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
100
|
|
Overall Study
Received Vaccination 1
|
199
|
99
|
|
Overall Study
Received Vaccination 2
|
188
|
92
|
|
Overall Study
Received Vaccination 3
|
186
|
90
|
|
Overall Study
COMPLETED
|
186
|
90
|
|
Overall Study
NOT COMPLETED
|
14
|
10
|
Reasons for withdrawal
| Measure |
CYD Dengue Vaccine Group
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
Participants received two injections of placebo, and 1 injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Overall Study
Other adverse event
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
13
|
6
|
|
Overall Study
Enrolled but not treated
|
1
|
1
|
Baseline Characteristics
Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years
Baseline characteristics by cohort
| Measure |
CYD Dengue Vaccine Group
n=199 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=99 Participants
Participants received two injections of placebo, and 1 injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Total
n=298 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.4 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
6.4 years
STANDARD_DEVIATION 2.9 • n=7 Participants
|
6.4 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Age, Customized
2 to 5 years
|
100 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Age, Customized
6 to 11 years
|
99 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3Population: Analysis was performed on Safety analysis set which included all participants who received at least 1 dose of dengue or control vaccine. Here, 'number analyzed' = participants with available data for specified category.
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=199 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=99 Participants
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Pain; Post-Inj. 1 (2-11 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Erythema;Post-Inj.1 (2-11 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Erythema;Post-Inj.3 (2-11 years)
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Inj. site Swelling; Post-Inj. 3 (2-11 years)
|
3.2 Percentage of participants
|
8.9 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Headache; Post-Inj. 1 (2-11 years)
|
0.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Malaise; Post-Inj. 1 (2-11 years)
|
33.7 Percentage of participants
|
23.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Myalgia; Post-Inj. 1 (2-11 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Asthenia; Post-Inj. 1 (2-11 years)
|
0.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Myalgia; Post-Inj. 2 (2-11 years)
|
14.9 Percentage of participants
|
10.9 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Asthenia; Post-Inj. 2 (2-11 years)
|
11.2 Percentage of participants
|
7.6 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Asthenia; Post-Inj. 2 (2-11 years)
|
0.5 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Myalgia; Post-Inj. 3 (2-11 years)
|
0.0 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Asthenia; Post-Inj. 3 (2-11 years)
|
10.2 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Inj. site Erythema; Post-Inj. 1 (2-11 years)
|
7.5 Percentage of participants
|
4.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Inj. site Pain; Post-Inj. 1 (2-11 years)
|
20.6 Percentage of participants
|
17.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Inj. site Swelling; Post-Inj. 1 (2-11 years)
|
5.5 Percentage of participants
|
5.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Swelling; Post-Inj.1(2-11 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Inj. site Pain; Post-Inj. 2 (2-11 years)
|
19.7 Percentage of participants
|
17.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Pain; Post-Inj. 2 (2-11 years)
|
0.0 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Inj. site Erythema; Post-Inj. 2 (2-11 years)
|
4.3 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Erythema;Post-Inj.2 (2-11 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Inj. site Swelling; Post-Inj. 2 (2-11 years)
|
2.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Swelling;Post-Inj.2 (2-11 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Inj. site Pain; Post-Inj. 3 (2-11 years)
|
17.7 Percentage of participants
|
32.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Pain; Post-Inj. 3 (2-11 years)
|
0.5 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Inj. site Erythema; Post-Inj. 3 (2-11 years)
|
4.3 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Swelling;Post-Inj.3 (2-11 years)
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Fever; Post-Inj. 1 (2-11 years)
|
31.3 Percentage of participants
|
10.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Fever; Post-Inj. 1 (2-11 years)
|
3.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Headache; Post-Inj. 1 (2-11 years)
|
35.7 Percentage of participants
|
16.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Malaise; Post-Inj. 1 (2-11 years)
|
0.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Myalgia; Post-Inj. 1 (2-11 years)
|
19.1 Percentage of participants
|
13.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Asthenia; Post-Inj. 1 (2-11 years)
|
13.6 Percentage of participants
|
13.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Fever; Post-Inj. 2 (2-11 years)
|
19.7 Percentage of participants
|
16.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Fever; Post-Inj. 2 (2-11 years)
|
0.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Headache; Post-Inj. 2 (2-11 years)
|
22.3 Percentage of participants
|
19.6 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Headache; Post-Inj. 2 (2-11 years)
|
0.5 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Malaise; Post-Inj. 2 (2-11 years)
|
18.1 Percentage of participants
|
16.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Malaise; Post-Inj. 2 (All ages)
|
0.5 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Myalgia; Post-Inj. 2 (2-11 years)
|
1.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Fever; Post-Inj. 3 (2-11 years)
|
18.4 Percentage of participants
|
22.5 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Fever; Post-Inj. 3 (2-11 years)
|
0.0 Percentage of participants
|
3.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Headache; Post-Inj. 3 (2-11 years)
|
18.8 Percentage of participants
|
27.8 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Headache; Post-Inj. 3 (2-11 years)
|
0.0 Percentage of participants
|
3.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Malaise; Post-Inj. 3 (2-11 years)
|
16.7 Percentage of participants
|
23.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Malaise; Post-Inj. 3 (2-11 years)
|
0.0 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Myalgia; Post-Inj. 3 (2-11 years)
|
13.4 Percentage of participants
|
26.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
Grade 3 Asthenia; Post-Inj. 3 (2-11 years)
|
0.0 Percentage of participants
|
1.1 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3Population: Analysis was performed on Safety analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=100 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=50 Participants
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Inj. site Pain: Post-Inj.1 (2-5 years)
|
19.0 Percentage of participants
|
16.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Pain; Post-Inj. 1 (2-5 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Inj. site Erythema; Post-Inj. 1 (2-5 years)
|
11.0 Percentage of participants
|
6.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Erythema;Post-Inj. 1 (2-5 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Inj. site Swelling; Post-Inj. 1 (2-5 years)
|
6.0 Percentage of participants
|
8.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Inj. site Erythema; Post-Inj. 2 (2-5 years)
|
4.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Erythema;Post-Inj. 2 (2-5 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Inj. site Pain; Post-Inj. 3 (2-5 years)
|
14.4 Percentage of participants
|
23.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Pain; Post-Inj. 3 (2-5 years)
|
0.0 Percentage of participants
|
4.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Erythema;Post-Inj. 3 (2-5 years
|
0.0 Percentage of participants
|
2.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Inj. site Swelling; Post-Inj. 3 (2-5 years)
|
3.3 Percentage of participants
|
7.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Fever; Post-Inj. 1 (2-5 years)
|
4.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Malaise; Post-Inj. 1 (2-5 years)
|
33.0 Percentage of participants
|
26.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Malaise; Post-Inj. 1 (2-5 years)
|
1.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Asthenia; Post-Inj. 1 (2-5 years)
|
13.0 Percentage of participants
|
12.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Asthenia; Post-Inj. 1 (2-5 years)
|
1.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Myalgia; Post-Inj. 2 (2-5 years)
|
9.8 Percentage of participants
|
6.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Asthenia; Post-Inj. 2 (2-5 years)
|
9.8 Percentage of participants
|
8.9 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Asthenia; Post-Inj. 2 (2-5 years)
|
1.1 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Malaise; Post-Inj. 3 (2-5 years)
|
6.7 Percentage of participants
|
23.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Inj. site Erythema; Post-Inj. 3 (2-5 years)
|
3.3 Percentage of participants
|
9.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Swelling;Post-Inj. 1 (2-5 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Inj. site Pain; Post-Inj. 2 (2-5 years)
|
17.4 Percentage of participants
|
15.6 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Pain; Post-Inj. 2 (2-5 years)
|
0.0 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Inj. site Swelling; Post-Inj. 2 (2-5 years)
|
2.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Swelling;Post-Inj. 2 (2-5 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Swelling;Post-Inj. 3 (2-5 years)
|
0.0 Percentage of participants
|
2.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Fever; Post-Inj. 1 (2-5 years)
|
36.4 Percentage of participants
|
16.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Headache; Post-Inj. 1 (2-5 years)
|
23.0 Percentage of participants
|
8.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Headache; Post-Inj. 1 (2-5 years)
|
1.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Myalgia; Post-Inj. 1 (2-5 years)
|
12.0 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Myalgia; Post-Inj. 1 (2-5 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Fever; Post-Inj. 2 (2-5 years)
|
23.9 Percentage of participants
|
17.8 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Fever; Post-Inj. 2 (2-5 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Headache; Post-Inj. 2 (2-5 years)
|
14.1 Percentage of participants
|
6.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Headache; Post-Inj. 2 (2-5 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Malaise; Post-Inj. 2 (2-5 years)
|
15.2 Percentage of participants
|
13.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Malaise; Post-Inj. 2 (2-5 years)
|
1.1 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Myalgia; Post-Inj. 2 (2-5 years)
|
1.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Fever; Post-Inj. 3 (2-5 years)
|
16.9 Percentage of participants
|
26.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Fever; Post-Inj. 3 (2-5 years)
|
0.0 Percentage of participants
|
7.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Headache; Post-Inj. 3 (2-5 years)
|
6.7 Percentage of participants
|
18.6 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Headache; Post-Inj. 3 (2-5 years)
|
0.0 Percentage of participants
|
2.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Malaise; Post-Inj. 3 (2-5 years)
|
0.0 Percentage of participants
|
2.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Myalgia; Post-Inj. 3 (2-5 years)
|
6.7 Percentage of participants
|
20.9 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Myalgia; Post-Inj. 3 (2-5 years)
|
0.0 Percentage of participants
|
2.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Asthenia; Post-Inj. 3 (2-5 years)
|
4.4 Percentage of participants
|
23.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Asthenia; Post-Inj. 3 (2-5 years)
|
0.0 Percentage of participants
|
2.3 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3Population: Analysis was performed on Safety analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=99 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=49 Participants
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Swelling; Post-Inj.2(6-11 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Erythema; Post-Inj.3(6-11 years)
|
0.0 Percentage of participants
|
4.3 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Swelling; Post-Inj.3(6-11 years)
|
0.0 Percentage of participants
|
4.3 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Malaise; Post-Inj. 1 (6-11 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Myalgia; Post-Inj. 1 (6-11 years)
|
26.3 Percentage of participants
|
16.3 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Myalgia; Post-Inj. 1 (6-11 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Myalgia; Post-Inj. 2 (6-11 years)
|
19.8 Percentage of participants
|
14.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Asthenia; Post-Inj. 2 (6-11 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Headache; Post-Inj. 3 (6-11 years)
|
0.0 Percentage of participants
|
4.3 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Malaise; Post-Inj. 3 (6-11 years)
|
26.0 Percentage of participants
|
23.4 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Malaise; Post-Inj. 3 (6-11 years)
|
0.0 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Asthenia; Post-Inj. 3 (6-11 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Inj. site Pain; Post-Inj.1 (6-11 years)
|
22.2 Percentage of participants
|
18.4 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Pain; Post-Inj. 1 (6-11 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Inj. site Erythema; Post-Inj. 1 (6-11 years)
|
4.0 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Erythema; Post-Inj.1(6-11 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Inj. site Swelling; Post-Inj. 1 (6-11 years)
|
5.1 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Swelling; Post-Inj.1(6-11 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Inj. site Pain; Post-Inj. 2 (6-11 years)
|
21.9 Percentage of participants
|
19.1 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Pain; Post-Inj. 2 (6-11 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Inj. site Erythema; Post-Inj. 2 (6-11 years)
|
4.2 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Erythema; Post-Inj.2(6-11 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Inj. site Swelling; Post-Inj. 2 (6-11 years)
|
2.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Inj. site Pain; Post-Inj. 3 (6-11 years)
|
20.8 Percentage of participants
|
40.4 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Pain; Post-Inj. 3 (6-11 years)
|
1.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Inj. site Erythema; Post-Inj. 3 (6-11 years)
|
5.2 Percentage of participants
|
12.8 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Inj. site Swelling; Post-Inj. 3 (6-11 years)
|
3.1 Percentage of participants
|
10.6 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Fever; Post-Inj. 1 (6-11 years)
|
26.3 Percentage of participants
|
4.1 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Fever; Post-Inj. 1 (6-11 years)
|
3.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Headache; Post-Inj. 1 (6-11 years)
|
48.5 Percentage of participants
|
24.5 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Headache; Post-Inj. 1 (6-11 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Malaise; Post-Inj. 1 (6-11 years)
|
34.3 Percentage of participants
|
20.4 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Asthenia; Post-Inj. 1 (6-11 years)
|
14.1 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Asthenia; Post-Inj. 1 (6-11 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Fever; Post-Inj. 2 (6-11 years)
|
15.6 Percentage of participants
|
14.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Fever; Post-Inj. 2 (6-11 years)
|
1.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Headache; Post-Inj. 2 (6-11 years)
|
30.2 Percentage of participants
|
31.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Headache; Post-Inj. 2 (6-11 years)
|
1.0 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Malaise; Post-Inj. 2 (6-11 years)
|
20.8 Percentage of participants
|
19.1 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Malaise; Post-Inj. 2 (6-11 years)
|
0.0 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Myalgia; Post-Inj. 2 (6-11 years)
|
1.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Asthenia; Post-Inj. 2 (6-11 years)
|
12.5 Percentage of participants
|
6.4 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Fever; Post-Inj. 3 (6-11 years)
|
19.8 Percentage of participants
|
19.1 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Fever; Post-Inj. 3 (6-11 years)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Headache; Post-Inj. 3 (6-11 years)
|
30.2 Percentage of participants
|
36.2 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Myalgia; Post-Inj. 3 (6-11 years)
|
19.8 Percentage of participants
|
31.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Myalgia; Post-Inj. 3 (6-11 years)
|
0.0 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Asthenia; Post-Inj. 3 (6-11 years)
|
15.6 Percentage of participants
|
10.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3Population: Analysis was performed on Full analysis set which included all the participants present at visit 1 and who received at least one dose of vaccine. Here, 'number analyzed' = participants with available data for specified category.
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=199 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=99 Participants
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; Pre-Inj. 1
|
29.6 Percentage of participants
|
38.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; Pre-Inj. 3
|
35.5 Percentage of participants
|
20.9 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; 28 days Post-Inj. 1
|
55.4 Percentage of participants
|
37.9 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; Pre-Inj. 2
|
42.3 Percentage of participants
|
39.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; 28 days Post-Inj. 2
|
98.4 Percentage of participants
|
39.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; Pre-Inj. 3
|
74.7 Percentage of participants
|
41.8 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; 28 days Post-Inj. 3
|
98.4 Percentage of participants
|
46.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; Pre-Inj. 1
|
17.1 Percentage of participants
|
21.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; 28 days Post-Inj. 1
|
40.4 Percentage of participants
|
21.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; Pre-Inj. 2
|
32.8 Percentage of participants
|
20.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; 28 days Post-Inj. 2
|
68.1 Percentage of participants
|
16.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; 28 days Post-Inj. 3
|
79.0 Percentage of participants
|
20.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; Pre-Inj. 1
|
30.7 Percentage of participants
|
38.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; 28 days Post-Inj.1
|
68.4 Percentage of participants
|
38.9 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; Pre-Inj. 2
|
51.9 Percentage of participants
|
39.8 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; 28 days Post-Inj. 2
|
100.0 Percentage of participants
|
40.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; Pre-Inj. 3
|
72.6 Percentage of participants
|
39.6 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; 28 days Post-Inj. 3
|
98.9 Percentage of participants
|
43.8 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; Pre-Inj. 1
|
14.1 Percentage of participants
|
18.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; 28 days Post-Inj. 1
|
74.1 Percentage of participants
|
18.9 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; Pre-Inj. 2
|
57.7 Percentage of participants
|
20.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; 28 days Post-Inj. 2
|
97.9 Percentage of participants
|
19.6 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; Pre-Inj. 3
|
82.8 Percentage of participants
|
18.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; 28 days Post-Inj. 3
|
98.9 Percentage of participants
|
23.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3Population: Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=100 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=50 Participants
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; 28 days Post-Inj. 1
|
54.7 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; Pre-Inj. 2
|
29.0 Percentage of participants
|
15.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; Pre-Inj. 1
|
30.0 Percentage of participants
|
32.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; Pre-Inj. 2
|
38.7 Percentage of participants
|
31.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; 28 days Post-Inj. 2
|
97.8 Percentage of participants
|
31.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; Pre-Inj. 3
|
72.2 Percentage of participants
|
36.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; 28 days Post-Inj. 3
|
98.9 Percentage of participants
|
44.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; Pre-Inj. 1
|
14.0 Percentage of participants
|
16.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; 28 days Post-Inj. 1
|
32.6 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; 28 days Post-Inj. 2
|
64.1 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; Pre-Inj. 3
|
28.9 Percentage of participants
|
18.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; 28 days Post-Inj. 3
|
77.8 Percentage of participants
|
20.9 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; Pre-Inj. 1
|
28.0 Percentage of participants
|
32.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; 28 days Post-Inj. 1
|
62.1 Percentage of participants
|
35.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; Pre-Inj. 2
|
45.2 Percentage of participants
|
32.6 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; 28 days Post-Inj. 2
|
100.0 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; Pre-Inj. 3
|
70.0 Percentage of participants
|
34.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; 28 days Post-Inj. 3
|
100.0 Percentage of participants
|
39.5 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; Pre-Inj. 1
|
13.0 Percentage of participants
|
18.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; 28 days Post-Inj. 1
|
74.7 Percentage of participants
|
22.9 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; Pre-Inj. 2
|
60.2 Percentage of participants
|
17.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; 28 days Post-Inj. 2
|
100.0 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; Pre-Inj. 3
|
87.8 Percentage of participants
|
22.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; 28 days Post-Inj. 3
|
100.0 Percentage of participants
|
27.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3Population: Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=99 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=49 Participants
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; 28 days Post-Inj 1
|
74.5 Percentage of participants
|
42.6 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; Pre-Inj. 2
|
55.2 Percentage of participants
|
23.4 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; 28 days Post-Inj. 2
|
95.8 Percentage of participants
|
19.1 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; 28 days Post-Inj. 3
|
97.9 Percentage of participants
|
19.6 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; Pre-Inj. 1
|
29.3 Percentage of participants
|
44.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; 28 days Post-Inj. 1
|
56.1 Percentage of participants
|
42.6 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; Pre-Inj. 2
|
45.8 Percentage of participants
|
46.8 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; 28 days Post-Inj. 2
|
99.0 Percentage of participants
|
46.8 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; Pre-Inj. 3
|
77.1 Percentage of participants
|
46.8 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; 28 days Post-Inj. 3
|
97.9 Percentage of participants
|
47.8 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; Pre-Inj. 1
|
20.2 Percentage of participants
|
26.5 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; 28 days Post-Inj. 1
|
48.0 Percentage of participants
|
25.5 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; Pre-Inj. 2
|
36.5 Percentage of participants
|
25.5 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; 28 days Post-Inj. 2
|
71.9 Percentage of participants
|
21.3 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; Pre-Inj. 3
|
41.7 Percentage of participants
|
23.4 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; 28 days Post-Inj. 3
|
80.2 Percentage of participants
|
19.6 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; Pre-Inj. 1
|
33.3 Percentage of participants
|
44.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; Pre-Inj. 2
|
58.3 Percentage of participants
|
46.8 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; 28 days Post-Inj. 2
|
100.0 Percentage of participants
|
46.8 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; Pre-Inj. 3
|
75.0 Percentage of participants
|
44.7 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; 28 days Post-Inj. 3
|
97.9 Percentage of participants
|
47.8 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; Pre-Inj. 1
|
15.2 Percentage of participants
|
18.4 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; 28 days Post-Inj. 1
|
73.5 Percentage of participants
|
14.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; Pre-Inj. 3
|
78.1 Percentage of participants
|
14.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28 days Post-Injection 2 and 3Population: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.
Seropositivity against the dengue virus serotypes was assessed by the plaque reduction neutralization test (PRNT). Seropositivity was defined as a titer \>= 10 1/dilution.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=199 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=99 Participants
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; 28 days Post-Inj. 2
|
94.7 Percentage of participants
|
39.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; 28 days Post-Inj. 3
|
96.2 Percentage of participants
|
48.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; Pre-Inj. 1
|
31.5 Percentage of participants
|
41.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; 28 days Post-Inj. 2
|
97.9 Percentage of participants
|
43.5 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; 28 days Post-Inj. 3
|
98.4 Percentage of participants
|
47.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; Pre-Inj. 1
|
35.0 Percentage of participants
|
46.5 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; 28 days Post-Inj. 3
|
98.9 Percentage of participants
|
48.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; Pre-Inj. 1
|
19.3 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; 28 days Post-Inj. 2
|
98.4 Percentage of participants
|
35.9 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; Pre-Inj. 1
|
30.6 Percentage of participants
|
36.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; 28 days Post-Inj. 2
|
98.9 Percentage of participants
|
51.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; 28 days Post-Inj. 3
|
98.4 Percentage of participants
|
67.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28 days Post-Injection 2 and 3Population: Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=100 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=50 Participants
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; 28 days Post-Inj. 3
|
100.0 Percentage of participants
|
44.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; 28 days Post-Inj. 3
|
100.0 Percentage of participants
|
46.5 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; Pre-Inj. 1
|
30.3 Percentage of participants
|
30.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; 28 days Post-Inj. 2
|
96.7 Percentage of participants
|
31.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; 28 days Post-Inj. 3
|
97.8 Percentage of participants
|
41.9 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; Pre-Inj. 1
|
30.3 Percentage of participants
|
38.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; 28 days Post-Inj. 2
|
96.7 Percentage of participants
|
37.8 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; Pre-Inj. 1
|
35.4 Percentage of participants
|
38.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; 28 days Post-Inj. 2
|
98.9 Percentage of participants
|
53.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; 28 days Post-Inj. 3
|
98.9 Percentage of participants
|
65.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; Pre-Inj. 1
|
16.2 Percentage of participants
|
22.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; 28 days Post-Inj. 2
|
97.8 Percentage of participants
|
35.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28 days Post-Injection 2 and 3Population: Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=99 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=49 Participants
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; Pre-Inj. 1
|
30.9 Percentage of participants
|
42.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; 28 days Post-Inj. 3
|
94.8 Percentage of participants
|
54.3 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; Pre-Inj. 1
|
32.7 Percentage of participants
|
44.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; 28 days Post-Inj. 3
|
97.9 Percentage of participants
|
69.6 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; Pre-Inj. 1
|
22.4 Percentage of participants
|
22.4 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 1; 28 days Post-Inj. 2
|
92.6 Percentage of participants
|
46.8 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; 28 days Post-Inj. 2
|
98.9 Percentage of participants
|
48.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 2; 28 days Post-Inj. 3
|
96.9 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; Pre-Inj. 1
|
34.7 Percentage of participants
|
55.1 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 3; 28 days Post-Inj. 2
|
98.9 Percentage of participants
|
48.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; 28 days Post-Inj. 2
|
98.9 Percentage of participants
|
36.2 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo
Dengue parental serotype 4; 28 days Post-Inj. 3
|
97.9 Percentage of participants
|
50.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3Population: Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=199 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=99 Participants
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 2 positive serotypes; Pre-Inj. 2
|
49.2 Percentage of participants
|
39.8 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 3 positive serotypes; 28 days Post-Inj. 1
|
52.8 Percentage of participants
|
25.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
All 4 positive serotypes; 28 days Post-Inj. 3
|
79.0 Percentage of participants
|
15.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 3 positive serotypes; 28 days Post-Inj. 3
|
98.4 Percentage of participants
|
25.8 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
All 4 positive serotypes; Pre-Inj. 1
|
10.6 Percentage of participants
|
13.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
All 4 positive serotypes; 28 days Post-Inj. 1
|
37.8 Percentage of participants
|
12.6 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
All 4 positive serotypes; Pre-Inj. 2
|
27.5 Percentage of participants
|
16.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
All 4 positive serotypes; 28 days Post-Inj. 2
|
66.0 Percentage of participants
|
10.9 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
All 4 positive serotypes; Pre-Inj. 3
|
33.9 Percentage of participants
|
13.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 1 positive serotype; Pre-Inj. 1
|
32.2 Percentage of participants
|
40.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 1 positive serotype; 28 days Post-Inj. 1
|
80.8 Percentage of participants
|
40.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 1 positive serotype; Pre-Inj. 2
|
69.8 Percentage of participants
|
40.9 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 1 positive serotype; 28 days Post-Inj. 2
|
100.0 Percentage of participants
|
42.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 1 positive serotype; Pre-Inj. 3
|
88.7 Percentage of participants
|
42.9 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 1 positive serotype; 28 days Post-Inj. 3
|
98.9 Percentage of participants
|
48.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 2 positive serotypes; Pre-Inj. 1
|
29.1 Percentage of participants
|
38.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 2 positive serotypes; 28 days Post-Inj. 1
|
66.8 Percentage of participants
|
38.9 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 2 positive serotypes; 28 days Post-Inj. 2
|
100.0 Percentage of participants
|
40.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 2 positive serotypes; Pre-Inj. 3
|
75.3 Percentage of participants
|
39.6 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 2 positive serotypes; 28 days Post-Inj. 3
|
98.9 Percentage of participants
|
43.8 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 3 positive serotypes; Pre-Inj. 1
|
19.6 Percentage of participants
|
24.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 3 positive serotypes; Pre-Inj. 2
|
38.1 Percentage of participants
|
22.6 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 3 positive serotypes; 28 days Post-Inj. 2
|
98.4 Percentage of participants
|
21.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 3 positive serotypes; Pre-Inj. 3
|
67.7 Percentage of participants
|
25.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3Population: Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>= 10 1/dilution.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=100 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=50 Participants
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 1 positive serotype; Pre-Inj. 1
|
31.0 Percentage of participants
|
34.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 1 positive serotype; Pre-Inj. 3
|
90.0 Percentage of participants
|
36.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 1 positive serotype; 28 days Post-Inj. 3
|
100.0 Percentage of participants
|
44.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 2 positive serotypes; Pre-Inj. 1
|
28.0 Percentage of participants
|
32.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 2 positive serotypes; Pre-Inj. 2
|
46.2 Percentage of participants
|
32.6 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 2 positive serotypes; 28 days Post-Inj. 2
|
100.0 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 2 positive serotypes; Pre-Inj. 3
|
75.6 Percentage of participants
|
34.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 3 positive serotypes; 28 days Post-Inj. 3
|
98.9 Percentage of participants
|
30.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
All 4 positive serotypes; Pre-Inj. 3
|
27.8 Percentage of participants
|
13.6 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
All 4 positive serotypes; 28 days Post-Inj. 3
|
77.8 Percentage of participants
|
18.6 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
All 4 positive serotypes; 28 days Post-Inj. 2
|
63.0 Percentage of participants
|
8.9 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 1 positive serotype; 28 days Post-Inj. 1
|
78.9 Percentage of participants
|
35.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 1 positive serotype; Pre-Inj. 2
|
67.7 Percentage of participants
|
32.6 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 1 positive serotype; 28 days Post-Inj. 2
|
100.0 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 2 positive serotypes; 28 days Post-Inj. 1
|
65.3 Percentage of participants
|
35.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 2 positive serotypes; 28 days Post-Inj. 3
|
100.0 Percentage of participants
|
39.5 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 3 positive serotypes; Pre-Inj. 1
|
17.0 Percentage of participants
|
24.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 3 positive serotypes; 28 days Post-Inj. 1
|
48.4 Percentage of participants
|
27.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 3 positive serotypes; Pre-Inj. 2
|
33.3 Percentage of participants
|
19.6 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 3 positive serotypes; 28 days Post-Inj. 2
|
98.9 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
At least 3 positive serotypes; Pre-Inj. 3
|
65.6 Percentage of participants
|
27.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
All 4 positive serotypes; Pre-Inj. 1
|
9.0 Percentage of participants
|
8.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
All 4 positive serotypes; 28 days Post-Inj. 1
|
31.6 Percentage of participants
|
10.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
All 4 positive serotypes; Pre-Inj. 2
|
25.8 Percentage of participants
|
10.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3Population: Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
Seropositivity for the dengue virus serotypes was assessed by the microneutralization assay. Seropositivity was defined as a titer \>=10 1/dilution.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=99 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=49 Participants
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
At least 1 positive serotype; Pre-Inj. 1
|
33.3 Percentage of participants
|
46.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
At least 1 positive serotype; 28 days Post-Inj. 3
|
97.9 Percentage of participants
|
52.2 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
At least 2 positive serotypes; Pre-Inj. 1
|
30.3 Percentage of participants
|
44.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
At least 2 positive serotypes; 28 days Post-Inj. 2
|
100.0 Percentage of participants
|
46.8 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
At least 2 positive serotypes; Pre-Inj. 3
|
75.0 Percentage of participants
|
44.7 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
At least 3 positive serotypes; 28 days Post-Inj. 1
|
57.1 Percentage of participants
|
23.4 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
At least 3 positive serotypes; Pre-Inj. 2
|
42.7 Percentage of participants
|
25.5 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
At least 3 positive serotypes; 28 days Post-Inj. 2
|
97.9 Percentage of participants
|
23.4 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
At least 3 positive serotypes; Pre-Inj. 3
|
69.8 Percentage of participants
|
23.4 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
At least 3 positive serotypes; 28 days Post-Inj. 3
|
97.9 Percentage of participants
|
21.7 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
All 4 positive serotypes; 28 days Post-Inj. 2
|
68.8 Percentage of participants
|
12.8 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
All 4 positive serotypes; Pre-Inj. 3
|
39.6 Percentage of participants
|
12.8 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
At least 1 positive serotype; 28 days Post-Inj. 1
|
82.7 Percentage of participants
|
44.7 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
At least 1 positive serotype; Pre-Inj. 2
|
71.9 Percentage of participants
|
48.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
At least 1 positive serotype; 28 days Post-Inj. 2
|
100.0 Percentage of participants
|
51.1 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
At least 1 positive serotype; Pre-Inj. 3
|
87.5 Percentage of participants
|
48.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
At least 2 positive serotypes; 28 days Post-Inj. 1
|
68.4 Percentage of participants
|
42.6 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
At least 2 positive serotypes; Pre-Inj. 2
|
52.1 Percentage of participants
|
46.8 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
At least 2 positive serotypes; 28 days Post-Inj. 3
|
97.9 Percentage of participants
|
47.8 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
At least 3 positive serotypes; Pre-Inj. 1
|
22.2 Percentage of participants
|
24.5 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
All 4 positive serotypes; Pre-Inj. 1
|
12.1 Percentage of participants
|
18.4 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
All 4 positive serotypes; 28 days Post-Inj. 1
|
43.9 Percentage of participants
|
14.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
All 4 positive serotypes; Pre-Inj. 2
|
29.2 Percentage of participants
|
21.3 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine
All 4 positive serotypes; 28 days Post-Inj. 3
|
80.2 Percentage of participants
|
13.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28 days Post-Injection 2 and 3Population: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=199 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=99 Participants
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
All 4 positive serotypes; 28 days Post-Inj. 3
|
94.1 Percentage of participants
|
39.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 1 positive serotype; Pre-Inj. 1
|
37.6 Percentage of participants
|
48.5 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 1 positive serotype; 28 days Post-Inj. 2
|
100.0 Percentage of participants
|
57.6 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 1 positive serotype; 28 days Post-Inj. 3
|
99.5 Percentage of participants
|
73.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 2 positive serotypes; Pre-Inj. 1
|
31.5 Percentage of participants
|
41.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 2 positive serotypes; 28 days Post-Inj. 2
|
99.5 Percentage of participants
|
41.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 2 positive serotypes; 28 days Post-Inj. 3
|
99.5 Percentage of participants
|
52.8 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 3 positive serotypes; Pre-Inj. 1
|
29.9 Percentage of participants
|
37.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 3 positive serotypes; 28 days Post-Inj. 2
|
98.4 Percentage of participants
|
41.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 3 positive serotypes; 28 days Post-Inj. 3
|
98.4 Percentage of participants
|
46.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
All 4 positive serotypes; Pre-Inj. 1
|
17.3 Percentage of participants
|
19.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
All 4 positive serotypes; 28 days Post-Inj. 2
|
90.9 Percentage of participants
|
29.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28 days Post-Injection 2 and 3Population: Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>= 10 1/dilution.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=100 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=50 Participants
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 1 positive serotype; 28 days Post-Inj. 2
|
100.0 Percentage of participants
|
64.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 3 positive serotypes; 28 days Post-Inj. 3
|
100 Percentage of participants
|
41.9 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
All 4 positive serotypes; Pre-Inj. 1
|
14.1 Percentage of participants
|
16.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
All 4 positive serotypes; 28 days Post-Inj. 2
|
90.2 Percentage of participants
|
26.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
All 4 positive serotypes; 28 days Post-Inj. 3
|
96.7 Percentage of participants
|
37.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 1 positive serotype; Pre-Inj. 1
|
39.4 Percentage of participants
|
42.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 1 positive serotype; 28 days Post-Inj. 3
|
100.0 Percentage of participants
|
74.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 2 positive serotypes; Pre-Inj. 1
|
30.3 Percentage of participants
|
36.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 2 positive serotypes; 28 days Post-Inj. 2
|
100.0 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 2 positive serotypes; 28 days Post-Inj. 3
|
100.0 Percentage of participants
|
44.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 3 positive serotypes; Pre-Inj. 1
|
28.3 Percentage of participants
|
34.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 3 positive serotypes; 28 days Post-Inj. 2
|
97.8 Percentage of participants
|
33.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28 days Post-Injection 2 and 3Population: Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for specified category.
Seropositivity against the dengue virus serotypes was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=99 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=49 Participants
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 2 positive serotypes; 28 days Post-Inj. 3
|
99.0 Percentage of participants
|
60.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 3 positive serotypes; Pre-Inj. 1
|
31.6 Percentage of participants
|
40.8 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 1 positive serotype; Pre-Inj. 1
|
35.7 Percentage of participants
|
55.1 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 1 positive serotype; 28 days Post-Inj. 2
|
100.0 Percentage of participants
|
51.1 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 1 positive serotype; 28 days Post-Inj. 3
|
99.0 Percentage of participants
|
71.7 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 2 positive serotypes; Pre-Inj. 1
|
32.7 Percentage of participants
|
46.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 2 positive serotypes; 28 days Post-Inj. 2
|
98.9 Percentage of participants
|
48.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 3 positive serotypes; 28 days Post-Inj. 2
|
98.9 Percentage of participants
|
48.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
At least 3 positive serotypes; 28 days Post-Inj. 3
|
96.9 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
All 4 positive serotypes; Pre-Inj. 1
|
20.4 Percentage of participants
|
22.4 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
All 4 positive serotypes; 28 days Post-Inj. 2
|
91.6 Percentage of participants
|
31.9 Percentage of participants
|
|
Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine
All 4 positive serotypes; 28 days Post-Inj. 3
|
91.7 Percentage of participants
|
41.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28 days Post-Injection 2 and 3Population: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.
GMTs of antibodies against parental dengue virus serotypes were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=199 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=99 Participants
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 1; Pre-Inj. 1, All
|
17.4 Titers (1/dilution)
Interval 13.0 to 23.2
|
22.8 Titers (1/dilution)
Interval 14.9 to 34.8
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 1; 28 days Post-Inj. 3, All
|
179 Titers (1/dilution)
Interval 143.0 to 224.0
|
38.1 Titers (1/dilution)
Interval 23.4 to 62.1
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 2; Pre-Inj. 1, All
|
14.4 Titers (1/dilution)
Interval 11.2 to 18.3
|
18.2 Titers (1/dilution)
Interval 12.8 to 25.8
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 2; 28 days Post-Inj. 2, All
|
151 Titers (1/dilution)
Interval 128.0 to 178.0
|
17.3 Titers (1/dilution)
Interval 12.5 to 23.9
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 2; 28 days Post-Inj. 3, All
|
178 Titers (1/dilution)
Interval 152.0 to 207.0
|
21.6 Titers (1/dilution)
Interval 14.8 to 31.5
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 3; Pre-Inj. 1, All
|
16.4 Titers (1/dilution)
Interval 12.7 to 21.2
|
21.8 Titers (1/dilution)
Interval 15.2 to 31.3
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 3; 28 days Post-Inj. 2, All
|
155 Titers (1/dilution)
Interval 129.0 to 186.0
|
26.6 Titers (1/dilution)
Interval 18.1 to 39.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 3; 28 days Post-Inj. 3, All
|
190 Titers (1/dilution)
Interval 162.0 to 224.0
|
36.2 Titers (1/dilution)
Interval 25.1 to 52.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 4; Pre-Inj. 1, All
|
8.12 Titers (1/dilution)
Interval 6.91 to 9.54
|
8.94 Titers (1/dilution)
Interval 6.97 to 11.5
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 4; 28 days Post-Inj. 2, All
|
144 Titers (1/dilution)
Interval 126.0 to 166.0
|
12.8 Titers (1/dilution)
Interval 9.5 to 17.2
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 1; 28 days Post-Inj. 2, 2-5 years
|
135 Titers (1/dilution)
Interval 97.2 to 187.0
|
19.0 Titers (1/dilution)
Interval 10.1 to 35.7
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 1; 28 days Post-Inj. 3, 2-5 years
|
205 Titers (1/dilution)
Interval 149.0 to 282.0
|
31.3 Titers (1/dilution)
Interval 14.9 to 65.9
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 3; 28 days Post-Inj. 2, 2-5 years
|
171 Titers (1/dilution)
Interval 131.0 to 224.0
|
26.5 Titers (1/dilution)
Interval 15.4 to 45.7
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 3; 28 days Post-Inj. 3, 2-5 years
|
214 Titers (1/dilution)
Interval 169.0 to 270.0
|
35.0 Titers (1/dilution)
Interval 20.3 to 60.6
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 4; Pre-Inj. 1, 2-5 years
|
7.76 Titers (1/dilution)
Interval 6.2 to 9.7
|
9.02 Titers (1/dilution)
Interval 6.27 to 13.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 4; 28 days Post-Inj. 2, 2-5 years
|
165 Titers (1/dilution)
Interval 134.0 to 203.0
|
14.4 Titers (1/dilution)
Interval 8.83 to 23.6
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 4; 28 days Post-Inj. 3, 2-5 years
|
223 Titers (1/dilution)
Interval 181.0 to 276.0
|
18.7 Titers (1/dilution)
Interval 11.2 to 31.4
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 1; Pre-Inj. 1, 6-11 years
|
18.4 Titers (1/dilution)
Interval 12.0 to 28.4
|
32.3 Titers (1/dilution)
Interval 16.6 to 63.1
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 1; 28 days Post-Inj. 2, 6-11 years
|
116 Titers (1/dilution)
Interval 81.7 to 165.0
|
36.2 Titers (1/dilution)
Interval 18.5 to 71.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 1; 28 days Post-Inj. 3, 6-11 years
|
157 Titers (1/dilution)
Interval 115.0 to 216.0
|
45.8 Titers (1/dilution)
Interval 23.6 to 88.8
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 2; Pre-Inj. 1, 6-11 years
|
17.5 Titers (1/dilution)
Interval 11.6 to 26.3
|
24.0 Titers (1/dilution)
Interval 13.4 to 43.1
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 2; 28 days Post-Inj. 2, 6-11 years
|
168 Titers (1/dilution)
Interval 130.0 to 216.0
|
22.3 Titers (1/dilution)
Interval 13.4 to 37.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 2; 28 days Post-Inj. 3, 6-11 years
|
163 Titers (1/dilution)
Interval 127.0 to 208.0
|
21.4 Titers (1/dilution)
Interval 12.9 to 35.6
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 3; Pre-Inj. 1, 6-11 years
|
16.6 Titers (1/dilution)
Interval 11.5 to 24.0
|
28.6 Titers (1/dilution)
Interval 16.7 to 48.7
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 3; 28 days Post-Inj. 2, 6-11 years
|
141 Titers (1/dilution)
Interval 109.0 to 182.0
|
26.6 Titers (1/dilution)
Interval 15.1 to 46.8
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 3; 28 days Post-Inj. 3, 6-11 years
|
171 Titers (1/dilution)
Interval 137.0 to 213.0
|
37.3 Titers (1/dilution)
Interval 22.5 to 61.6
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 4; Pre-Inj. 1, 6-11 years
|
8.50 Titers (1/dilution)
Interval 6.72 to 10.8
|
8.87 Titers (1/dilution)
Interval 6.21 to 12.6
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 4; 28 days Post-Inj. 2, 6-11 years
|
127 Titers (1/dilution)
Interval 106.0 to 153.0
|
11.4 Titers (1/dilution)
Interval 7.96 to 16.3
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 4; 28 days Post-Inj. 3, 6-11 years
|
152 Titers (1/dilution)
Interval 126.0 to 184.0
|
15.0 Titers (1/dilution)
Interval 10.2 to 22.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 1; 28 days Post-Inj. 2, All
|
125 Titers (1/dilution)
Interval 98.5 to 159.0
|
26.4 Titers (1/dilution)
Interval 16.7 to 41.8
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 4; 28 days Post-Inj. 3, All
|
184 Titers (1/dilution)
Interval 159.0 to 212.0
|
16.7 Titers (1/dilution)
Interval 12.2 to 22.8
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 1; Pre-Inj. 1, 2-5 years
|
16.4 Titers (1/dilution)
Interval 11.1 to 24.3
|
16.2 Titers (1/dilution)
Interval 9.47 to 27.5
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 2; Pre-Inj. 1, 2-5 years
|
11.8 Titers (1/dilution)
Interval 8.94 to 15.6
|
13.9 Titers (1/dilution)
Interval 9.31 to 20.6
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 2; 28 days Post-Inj. 2, 2-5 years
|
135 Titers (1/dilution)
Interval 109.0 to 168.0
|
13.2 Titers (1/dilution)
Interval 8.8 to 19.9
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 2; 28 days Post-Inj. 3, 2-5 years
|
195 Titers (1/dilution)
Interval 163.0 to 234.0
|
21.8 Titers (1/dilution)
Interval 12.1 to 39.2
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo
Serotype 3; Pre-Inj. 1, 2-5 years
|
16.2 Titers (1/dilution)
Interval 11.2 to 23.4
|
16.7 Titers (1/dilution)
Interval 10.2 to 27.4
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28 days Post-Injection 1Population: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.
Seropositivity for yellow fever was assessed by the PRNT. Seropositivity was defined as a titer \>=10 1/dilution. Percentage values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=199 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=99 Participants
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo
Pre-Inj. 1; All participants
|
81.4 Percentage of participants
|
83.8 Percentage of participants
|
|
Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo
28 days Post-Inj. 1; All participants
|
86.5 Percentage of participants
|
83.2 Percentage of participants
|
|
Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo
Pre-Inj. 1; 2-5 years
|
68.0 Percentage of participants
|
74.0 Percentage of participants
|
|
Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo
28 days Post-Inj. 1; 2-5 years
|
76.6 Percentage of participants
|
72.9 Percentage of participants
|
|
Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo
Pre-Inj. 1; 6-11 years
|
94.9 Percentage of participants
|
93.9 Percentage of participants
|
|
Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo
28 days Post-Inj. 1; 6-11 years
|
95.9 Percentage of participants
|
93.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1 and 28 days Post-Injection 1Population: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.
GMTs of antibodies against yellow fever virus were assessed by the PRNT. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=199 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=99 Participants
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo
28 days Post-Inj. 1; 2-5 years
|
22.4 Titers (1/dilution)
Interval 17.5 to 28.7
|
21.2 Titers (1/dilution)
Interval 14.4 to 31.1
|
|
GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo
Pre-Inj. 1; 6-11 years
|
66.1 Titers (1/dilution)
Interval 52.8 to 82.9
|
63.9 Titers (1/dilution)
Interval 45.8 to 89.2
|
|
GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo
28 days Post-Inj. 1; 6-11 years
|
82.9 Titers (1/dilution)
Interval 66.2 to 104.0
|
61.8 Titers (1/dilution)
Interval 44.0 to 86.7
|
|
GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo
Pre-Inj. 1; All participants
|
32.3 Titers (1/dilution)
Interval 26.5 to 39.4
|
36.0 Titers (1/dilution)
Interval 27.1 to 47.7
|
|
GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo
28 days Post-Inj. 1; All participants
|
43.7 Titers (1/dilution)
Interval 36.1 to 52.8
|
36.0 Titers (1/dilution)
Interval 27.3 to 47.3
|
|
GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo
Pre-Inj. 1; 2-5 years
|
15.9 Titers (1/dilution)
Interval 12.3 to 20.6
|
20.5 Titers (1/dilution)
Interval 13.7 to 30.7
|
SECONDARY outcome
Timeframe: Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3Population: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for specified category.
GMTs of antibodies against parental dengue virus serotypes were assessed by the microneutralization assay. GMTs values are reported for all participants in each reporting arm and also separately for participants with age 2-5 years and 6-11 years.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=199 Participants
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=99 Participants
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 2; 28 days Post-Inj. 1, 2-5 years
|
12.7 Titers (1/dilution)
Interval 9.35 to 17.3
|
6.73 Titers (1/dilution)
Interval 5.39 to 8.41
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 2; Pre-Inj. 2, 2-5 years
|
10.1 Titers (1/dilution)
Interval 7.85 to 12.9
|
6.28 Titers (1/dilution)
Interval 5.19 to 7.61
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 2; 28 days Post-Inj. 2, 2-5 years
|
17.1 Titers (1/dilution)
Interval 13.4 to 21.8
|
6.13 Titers (1/dilution)
Interval 5.06 to 7.44
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 2; Pre-Inj. 3, 2-5 years
|
9.03 Titers (1/dilution)
Interval 7.17 to 11.4
|
6.68 Titers (1/dilution)
Interval 5.37 to 8.32
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 2; 28 days Post-Inj. 3, 2-5 years
|
19.7 Titers (1/dilution)
Interval 15.9 to 24.5
|
7.93 Titers (1/dilution)
Interval 5.76 to 10.9
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 3; Pre-Inj. 1, 2-5 years
|
11.8 Titers (1/dilution)
Interval 8.54 to 16.4
|
12.2 Titers (1/dilution)
Interval 8.0 to 18.7
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 3; 28 days Post-Inj. 1, 2-5 years
|
37.4 Titers (1/dilution)
Interval 23.9 to 58.3
|
12.9 Titers (1/dilution)
Interval 8.39 to 20.0
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 3; 28 days Post-Inj. 2, 2-5 years
|
129 Titers (1/dilution)
Interval 104.0 to 160.0
|
12.6 Titers (1/dilution)
Interval 8.01 to 19.7
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 3; Pre-Inj. 3, 2-5 years
|
26.7 Titers (1/dilution)
Interval 18.7 to 38.2
|
12.2 Titers (1/dilution)
Interval 7.85 to 19.1
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 3; 28 days Post-Inj. 3, 2-5 years
|
108 Titers (1/dilution)
Interval 86.9 to 135.0
|
15.3 Titers (1/dilution)
Interval 9.29 to 25.2
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 4; Pre-Inj. 1, 2-5 years
|
7.04 Titers (1/dilution)
Interval 5.67 to 8.74
|
7.74 Titers (1/dilution)
Interval 5.6 to 10.7
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 4; Pre-Inj. 2, 2-5 years
|
22.3 Titers (1/dilution)
Interval 16.0 to 31.0
|
7.64 Titers (1/dilution)
Interval 5.53 to 10.6
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 1; 28 days Post-Inj.1, All
|
43.1 Titers (1/dilution)
Interval 30.0 to 61.9
|
22.8 Titers (1/dilution)
Interval 14.8 to 35.1
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 1; Pre-Inj. 2, All
|
29.2 Titers (1/dilution)
Interval 20.5 to 41.7
|
26.0 Titers (1/dilution)
Interval 16.2 to 41.5
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 1; 28 days Post-Inj. 3, All
|
254 Titers (1/dilution)
Interval 203.0 to 318.0
|
35.3 Titers (1/dilution)
Interval 21.2 to 58.7
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 2; Pre-Inj. 2, All
|
11.6 Titers (1/dilution)
Interval 9.52 to 14.1
|
7.32 Titers (1/dilution)
Interval 6.06 to 8.84
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 2; 28 days Post-Inj. 2, All
|
21.4 Titers (1/dilution)
Interval 17.6 to 25.9
|
6.99 Titers (1/dilution)
Interval 5.82 to 8.39
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 2; 28 days Post-Inj. 3, All
|
22.3 Titers (1/dilution)
Interval 18.9 to 26.4
|
7.73 Titers (1/dilution)
Interval 6.24 to 9.58
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 3; Pre-Inj. 1, All
|
13.1 Titers (1/dilution)
Interval 10.3 to 16.5
|
16.3 Titers (1/dilution)
Interval 11.6 to 22.8
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 3; 28 days Post-Inj. 2, All
|
128 Titers (1/dilution)
Interval 108.0 to 150.0
|
15.5 Titers (1/dilution)
Interval 11.2 to 21.5
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 3; 28 days Post-Inj. 3, All
|
99.2 Titers (1/dilution)
Interval 84.8 to 116.0
|
16.0 Titers (1/dilution)
Interval 11.5 to 22.2
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 4; Pre-Inj. 1, All
|
7.52 Titers (1/dilution)
Interval 6.37 to 8.87
|
8.08 Titers (1/dilution)
Interval 6.39 to 10.2
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 4; 28 days Post-Inj.1, All
|
87.9 Titers (1/dilution)
Interval 65.4 to 118.0
|
7.84 Titers (1/dilution)
Interval 6.25 to 9.83
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 4; Pre-Inj. 2, All
|
21.3 Titers (1/dilution)
Interval 16.9 to 26.8
|
7.73 Titers (1/dilution)
Interval 6.27 to 9.53
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 4; 28 days Post-Inj. 2, All
|
158 Titers (1/dilution)
Interval 134.0 to 186.0
|
7.81 Titers (1/dilution)
Interval 6.27 to 9.74
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 4; Pre-Inj. 3, All
|
39.2 Titers (1/dilution)
Interval 31.7 to 48.5
|
7.49 Titers (1/dilution)
Interval 6.06 to 9.26
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 1; Pre-Inj. 1, 2-5 years
|
20.3 Titers (1/dilution)
Interval 12.9 to 32.0
|
18.6 Titers (1/dilution)
Interval 10.4 to 33.4
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 1; 28 days Post-Inj. 1, 2-5 years
|
44.8 Titers (1/dilution)
Interval 25.9 to 77.3
|
19.6 Titers (1/dilution)
Interval 10.6 to 36.1
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 1; 28 days Post-Inj. 2, 2-5 years
|
281 Titers (1/dilution)
Interval 204.0 to 386.0
|
20.9 Titers (1/dilution)
Interval 10.5 to 41.7
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 1; Pre-Inj. 3, 2-5 years
|
65.2 Titers (1/dilution)
Interval 39.6 to 107.0
|
22.1 Titers (1/dilution)
Interval 11.0 to 44.5
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 3; Pre-Inj. 2, 2-5 years
|
19.8 Titers (1/dilution)
Interval 13.4 to 29.4
|
12.3 Titers (1/dilution)
Interval 7.92 to 19.0
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 4; 28 days Post-Inj. 1, 2-5 years
|
114 Titers (1/dilution)
Interval 74.0 to 176.0
|
8.43 Titers (1/dilution)
Interval 5.97 to 11.9
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 1; 28 days Post-Inj. 1, 6-11 years
|
41.5 Titers (1/dilution)
Interval 25.5 to 67.5
|
26.7 Titers (1/dilution)
Interval 14.2 to 50.0
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 1; Pre-Inj. 2, 6-11 years
|
27.4 Titers (1/dilution)
Interval 17.2 to 43.6
|
33.9 Titers (1/dilution)
Interval 17.2 to 66.9
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 2; Pre-Inj. 1, 6-11 years
|
8.57 Titers (1/dilution)
Interval 6.67 to 11.0
|
9.32 Titers (1/dilution)
Interval 6.48 to 13.4
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 2; 28 days Post-Inj. 1, 6-11 years
|
18.8 Titers (1/dilution)
Interval 13.5 to 26.2
|
8.40 Titers (1/dilution)
Interval 6.07 to 11.6
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 2; 28 days Post-Inj. 2, 6-11 years
|
26.5 Titers (1/dilution)
Interval 19.7 to 35.7
|
7.92 Titers (1/dilution)
Interval 5.82 to 10.8
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 2; Pre-Inj. 3, 6-11 years
|
14.1 Titers (1/dilution)
Interval 10.5 to 19.0
|
7.85 Titers (1/dilution)
Interval 5.75 to 10.7
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 3; Pre-Inj. 1, 6-11 years
|
14.4 Titers (1/dilution)
Interval 10.3 to 20.2
|
21.8 Titers (1/dilution)
Interval 12.8 to 37.1
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 3; 28 days Post-Inj. 2, 6-11 years
|
126 Titers (1/dilution)
Interval 98.6 to 162.0
|
19.1 Titers (1/dilution)
Interval 11.8 to 30.8
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 3; Pre-Inj. 3, 6-11 years
|
35.6 Titers (1/dilution)
Interval 25.3 to 50.0
|
15.8 Titers (1/dilution)
Interval 10.2 to 24.6
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 3; 28 days Post-Inj. 3, 6-11 years
|
91.3 Titers (1/dilution)
Interval 73.0 to 114.0
|
16.7 Titers (1/dilution)
Interval 10.7 to 26.0
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 4; Pre-Inj. 1, 6-11 years
|
8.03 Titers (1/dilution)
Interval 6.23 to 10.3
|
8.43 Titers (1/dilution)
Interval 5.94 to 12.0
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 1; 28 days Post-Inj. 3, 2-5 years
|
315 Titers (1/dilution)
Interval 228.0 to 436.0
|
35.9 Titers (1/dilution)
Interval 16.4 to 78.6
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 1; Pre-Inj. 1, All
|
18.8 Titers (1/dilution)
Interval 13.8 to 25.6
|
23.9 Titers (1/dilution)
Interval 15.5 to 36.9
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 2; Pre-Inj. 1, 2-5 years
|
6.66 Titers (1/dilution)
Interval 5.63 to 7.88
|
6.48 Titers (1/dilution)
Interval 5.3 to 7.92
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 4; 28 days Post-Inj. 3, All
|
147 Titers (1/dilution)
Interval 126.0 to 172.0
|
8.54 Titers (1/dilution)
Interval 6.71 to 10.9
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 1; Pre-Inj. 2, 2-5 years
|
31.3 Titers (1/dilution)
Interval 18.1 to 53.9
|
19.7 Titers (1/dilution)
Interval 10.1 to 38.2
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 1; 28 days Post-Inj. 2, All
|
214 Titers (1/dilution)
Interval 171.0 to 266.0
|
26.1 Titers (1/dilution)
Interval 16.3 to 42.0
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 1; Pre-Inj. 3, All
|
64.1 Titers (1/dilution)
Interval 46.1 to 89.2
|
28.9 Titers (1/dilution)
Interval 17.7 to 49.3
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 2; Pre-Inj. 1, All
|
7.55 Titers (1/dilution)
Interval 6.5 to 8.78
|
7.76 Titers (1/dilution)
Interval 6.31 to 9.53
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 2; 28 days Post-Inj.1, All
|
15.5 Titers (1/dilution)
Interval 12.4 to 19.4
|
7.51 Titers (1/dilution)
Interval 6.19 to 9.12
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 2; Pre-Inj. 3, All
|
11.4 Titers (1/dilution)
Interval 9.39 to 13.8
|
7.26 Titers (1/dilution)
Interval 6.01 to 8.78
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 3; 28 days Post-Inj.1, All
|
41.4 Titers (1/dilution)
Interval 30.9 to 55.4
|
15.3 Titers (1/dilution)
Interval 11.0 to 21.3
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 3; Pre-Inj. 2, All
|
22.6 Titers (1/dilution)
Interval 17.3 to 29.5
|
15.4 Titers (1/dilution)
Interval 11.2 to 21.2
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 3; Pre-Inj. 3, All
|
31.0 Titers (1/dilution)
Interval 24.3 to 39.6
|
14.0 Titers (1/dilution)
Interval 10.3 to 19.0
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 4; 28 days Post-Inj. 2, 2-5 years
|
200 Titers (1/dilution)
Interval 166.0 to 240.0
|
8.22 Titers (1/dilution)
Interval 5.76 to 11.7
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 4; Pre-Inj. 3, 2-5 years
|
39.4 Titers (1/dilution)
Interval 29.5 to 52.8
|
7.97 Titers (1/dilution)
Interval 5.69 to 11.2
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 4; 28 days Post-Inj. 3, 2-5 years
|
176 Titers (1/dilution)
Interval 143.0 to 217.0
|
9.37 Titers (1/dilution)
Interval 6.35 to 13.8
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 1; Pre-Inj. 1, 6-11 years
|
17.4 Titers (1/dilution)
Interval 11.4 to 26.6
|
31.0 Titers (1/dilution)
Interval 16.1 to 59.6
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 1; 28 days Post-Inj. 2, 6-11 years
|
165 Titers (1/dilution)
Interval 122.0 to 222.0
|
32.4 Titers (1/dilution)
Interval 16.6 to 63.2
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 1; Pre-Inj. 3, 6-11 years
|
63.2 Titers (1/dilution)
Interval 40.5 to 98.7
|
37.2 Titers (1/dilution)
Interval 18.4 to 75.4
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 1;28 days Post-Inj. 3, 6-11 years
|
207 Titers (1/dilution)
Interval 152.0 to 283.0
|
34.7 Titers (1/dilution)
Interval 17.4 to 69.1
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 2; Pre-Inj. 2, 6-11 years
|
13.3 Titers (1/dilution)
Interval 9.8 to 18.0
|
8.50 Titers (1/dilution)
Interval 6.14 to 11.8
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 2; 28 days Post-Inj. 3, 6-11 years
|
25.0 Titers (1/dilution)
Interval 19.4 to 32.3
|
7.55 Titers (1/dilution)
Interval 5.59 to 10.2
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 3; 28 days Post-Inj. 1, 6-11 years
|
45.6 Titers (1/dilution)
Interval 31.0 to 67.1
|
18.3 Titers (1/dilution)
Interval 11.0 to 30.4
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 3; Pre-Inj. 2, 6-11 years
|
25.6 Titers (1/dilution)
Interval 17.8 to 37.0
|
19.2 Titers (1/dilution)
Interval 11.9 to 31.1
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 4; 28 days Post-Inj. 1, 6-11 years
|
68.2 Titers (1/dilution)
Interval 45.6 to 102.0
|
7.28 Titers (1/dilution)
Interval 5.36 to 9.88
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 4; Pre-Inj. 2, 6-11 years
|
20.3 Titers (1/dilution)
Interval 14.6 to 28.1
|
7.82 Titers (1/dilution)
Interval 5.9 to 10.3
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 4; 28 days Post-Inj. 2, 6-11 years
|
126 Titers (1/dilution)
Interval 96.3 to 164.0
|
7.44 Titers (1/dilution)
Interval 5.63 to 9.83
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 4; Pre-Inj. 3, 6-11 years
|
39.0 Titers (1/dilution)
Interval 28.6 to 53.2
|
7.06 Titers (1/dilution)
Interval 5.37 to 9.29
|
|
GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo
Serotype 4; 28 days Post-Inj. 3, 6-11 years
|
125 Titers (1/dilution)
Interval 98.9 to 157.0
|
7.82 Titers (1/dilution)
Interval 5.79 to 10.6
|
Adverse Events
CYD Dengue Vaccine Group
Serious events: 2 serious events
Other events: 71 other events
Deaths: 0 deaths
Control Group
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CYD Dengue Vaccine Group
n=199 participants at risk
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=99 participants at risk
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/199 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/199 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
1.0%
1/99 • Number of events 2 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Vascular purpura
|
0.50%
1/199 • Number of events 1 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
0.00%
0/99 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Epiphyseal disorder
|
0.50%
1/199 • Number of events 1 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
0.00%
0/99 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/199 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/199 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
1.0%
1/99 • Number of events 1 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
Other adverse events
| Measure |
CYD Dengue Vaccine Group
n=199 participants at risk
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
Control Group
n=99 participants at risk
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
|
|---|---|---|
|
General disorders
Injection site Pain; Post-injection 1, All participants
|
20.6%
41/199 • Number of events 41 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
17.2%
17/99 • Number of events 17 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
General disorders
Injection site Erythema; Post-injection 1, All participants
|
7.5%
15/199 • Number of events 15 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
4.0%
4/99 • Number of events 4 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
General disorders
Injection site Swelling; Post-injection 1, all participants
|
5.5%
11/199 • Number of events 11 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
5.1%
5/99 • Number of events 5 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
General disorders
Injection site Pain; Post-injection 2, All participants
|
19.7%
37/188 • Number of events 37 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
17.4%
16/92 • Number of events 16 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
General disorders
Injection site Pain; Post-injection 3, All participants
|
17.7%
33/186 • Number of events 33 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
32.2%
29/90 • Number of events 29 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
General disorders
Injection site Erythema; Post-injection 3, All participants
|
4.3%
8/186 • Number of events 8 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
11.1%
10/90 • Number of events 10 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
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General disorders
Injection site Swelling; Post-injection 3, All participants
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3.2%
6/186 • Number of events 6 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
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8.9%
8/90 • Number of events 8 • Adverse event (AE) data was collected from Day 0 (post-vaccination) up to 28 days post-injection 3. Solicited Reaction (SR) data were collected within 7 and 14 days after vaccination. Serious adverse event (SAE) data were collected throughout the study.
Analysis was performed on Safety Analysis Set. A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
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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 participant 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