Trial Outcomes & Findings for Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore (NCT NCT00880893)
NCT ID: NCT00880893
Last Updated: 2022-03-21
Results Overview
Seropositivity against each dengue virus serotype (parental strains) was assessed using a dengue plaque reduction neutralization test (PRNT) assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1198 participants
Primary outcome timeframe
Pre-Injection 1, 2, and 3 and 28 days Post-Injection 1, 2, and 3
Results posted on
2022-03-21
Participant Flow
Study participants were enrolled from 07 April 2009 to 08 October 2009 at 5 clinical sites in Singapore.
A total of 1198 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized.
Participant milestones
| Measure |
CYD Dengue Vaccine Group
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Overall Study
STARTED
|
898
|
300
|
|
Overall Study
COMPLETED
|
791
|
255
|
|
Overall Study
NOT COMPLETED
|
107
|
45
|
Reasons for withdrawal
| Measure |
CYD Dengue Vaccine Group
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
13
|
1
|
|
Overall Study
Withdrawal by Subject
|
15
|
11
|
|
Overall Study
Lost to Follow-up
|
76
|
33
|
|
Overall Study
Serious adverse event
|
3
|
0
|
Baseline Characteristics
Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore
Baseline characteristics by cohort
| Measure |
CYD Dengue Vaccine Group
n=898 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=300 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
Total
n=1198 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.1 Years
STANDARD_DEVIATION 12.0 • n=93 Participants
|
21.7 Years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
22.0 Years
STANDARD_DEVIATION 11.9 • n=27 Participants
|
|
Age, Customized
2-11 years
|
236 Participants
n=93 Participants
|
80 Participants
n=4 Participants
|
316 Participants
n=27 Participants
|
|
Age, Customized
12-17 years
|
141 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
187 Participants
n=27 Participants
|
|
Age, Customized
18-45 years
|
521 Participants
n=93 Participants
|
174 Participants
n=4 Participants
|
695 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
471 Participants
n=93 Participants
|
139 Participants
n=4 Participants
|
610 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
427 Participants
n=93 Participants
|
161 Participants
n=4 Participants
|
588 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to 14 days post-any and each injectionPopulation: Analysis was performed on Safety analysis set. Here, 'number analyzed' = participants with available data for each specified category.
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions (2-11 years): Pain, incapacitating, unable to perform usual activities; Erythema and Swelling, \>=5 cm. Grade 3 Solicited injection site reactions (adolescents and adults: \>=12 years): Pain, significant; prevents daily activity; Erythema and Swelling: \>10 cm. Grade 3 Solicited systemic reactions (all participants): Fever, \>=39.0°C; Headache, Malaise, Myalgia, and Asthenia: significant; prevents daily activity.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=898 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=300 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Injection site Pain; Post-Any Injection
|
53.9 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Injection site Pain; Post-Any Injection
|
1.0 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Injection site Erythema; Post-Any Injection
|
7.2 Percentage of participants
|
15.2 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Erythema; Post-Any Inj.
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Injection site Swelling; Post-Any Injection
|
4.1 Percentage of participants
|
8.4 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Inj. site Swelling; Post-Any Inj.
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Injection site Pain; Post-Injection 1
|
31.3 Percentage of participants
|
21.9 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Injection site Pain; Post- Injection 1
|
0.3 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Injection site Erythema; Post-Injection 1
|
2.0 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Injection site Erythema; Post- Injection 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Injection site Swelling; Post-Injection 1
|
1.1 Percentage of participants
|
1.7 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Injection site Swelling; Post- Injection 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Injection site Pain; Post-Injection 2
|
36.9 Percentage of participants
|
54.4 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Injection site Pain; Post- Injection 2
|
0.5 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Injection site Erythema; Post-Injection 2
|
3.4 Percentage of participants
|
8.8 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Injection site Erythema; Post- Injection 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Injection site Swelling; Post-Injection 2
|
1.4 Percentage of participants
|
3.5 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Injection site Swelling; Post- Injection 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Injection site Pain; Post-Injection 3
|
34.9 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Injection site Pain; Post- Injection 3
|
0.2 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Injection site Erythema; Post-Injection 3
|
3.8 Percentage of participants
|
9.4 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Injection site Erythema; Post- Injection 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Injection site Swelling; Post-Injection 3
|
2.6 Percentage of participants
|
5.8 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Injection site Swelling; Post- Injection 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Fever; Post-Any Injection
|
11.3 Percentage of participants
|
7.4 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Fever; Post-Any Injection
|
1.9 Percentage of participants
|
1.0 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Headache; Post-Any Injection
|
45.1 Percentage of participants
|
38.4 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Headache; Post-Any Injection
|
3.8 Percentage of participants
|
2.7 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Malaise; Post-Any Injection
|
41.8 Percentage of participants
|
35.4 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Malaise; Post-Any Injection
|
4.3 Percentage of participants
|
2.7 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Myalgia; Post-Any Injection
|
44.2 Percentage of participants
|
43.8 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Myalgia; Post-Any Injection
|
2.6 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Asthenia; Post-Any Injection
|
20.5 Percentage of participants
|
17.5 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Asthenia; Post-Any Injection
|
1.3 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Fever; Post-Injection 1
|
4.6 Percentage of participants
|
2.7 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Fever; Post-Injection 1
|
0.6 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Headache; Post-Injection 1
|
30.0 Percentage of participants
|
27.3 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Headache; Post-Injection 1
|
2.4 Percentage of participants
|
1.3 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Malaise; Post-Injection 1
|
25.0 Percentage of participants
|
18.2 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Malaise; Post-Injection 1
|
2.0 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Myalgia; Post-Injection 1
|
29.4 Percentage of participants
|
19.2 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Myalgia; Post-Injection 1
|
1.3 Percentage of participants
|
1.0 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Asthenia; Post-Injection 1
|
12.8 Percentage of participants
|
6.1 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Asthenia; Post-Injection 1
|
0.7 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Fever; Post-Injection 2
|
3.3 Percentage of participants
|
2.8 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Fever; Post-Injection 2
|
0.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Headache; Post-Injection 2
|
22.8 Percentage of participants
|
21.8 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Headache; Post-Injection 2
|
0.7 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Malaise; Post-Injection 2
|
19.1 Percentage of participants
|
18.2 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Malaise; Post-Injection 2
|
1.2 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Myalgia; Post-Injection 2
|
24.0 Percentage of participants
|
29.5 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Myalgia; Post-Injection 2
|
0.9 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Asthenia; Post-Injection 2
|
9.3 Percentage of participants
|
10.2 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Asthenia; Post-Injection 2
|
0.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Fever; Post-Injection 3
|
4.8 Percentage of participants
|
2.9 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Fever; Post-Injection 3
|
0.8 Percentage of participants
|
0.4 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Headache; Post-Injection 3
|
20.1 Percentage of participants
|
19.8 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Headache; Post-Injection 3
|
1.0 Percentage of participants
|
0.4 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Malaise; Post-Injection 3
|
18.2 Percentage of participants
|
17.3 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Malaise; Post-Injection 3
|
1.4 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Myalgia; Post-Injection 3
|
21.8 Percentage of participants
|
26.3 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Myalgia; Post-Injection 3
|
0.5 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Asthenia; Post-Injection 3
|
8.5 Percentage of participants
|
9.4 Percentage of participants
|
|
Percentage of All Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
Grade 3 Asthenia; Post-Injection 3
|
0.4 Percentage of participants
|
0.4 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 0 up to 14 days post-each injectionPopulation: Analysis was performed on Safety analysis set. Here, 'number analyzed' = participants with available data for each specified category.
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=898 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=300 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Headache, Post-Inj. 1
|
29.7 Percentage of participants
|
29.2 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Injection site Pain, Post-Inj. 1
|
33.9 Percentage of participants
|
30.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Inj. site Erythema, Post-Inj. 1
|
6.4 Percentage of participants
|
7.5 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Inj. site Swelling, Post-Inj. 1
|
3.8 Percentage of participants
|
6.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Injection site Pain, Post- Inj. 1
|
28.4 Percentage of participants
|
28.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Inj. site Erythema, Post- Inj. 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Inj. site Swelling, Post-Inj. 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Injection site Pain, Post- Inj. 1
|
30.9 Percentage of participants
|
16.4 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Inj. site Erythema, Post- Inj. 1
|
0.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Inj. site Swelling, Post-Inj. 1
|
0.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Injection site Pain, Post- Inj. 2
|
38.3 Percentage of participants
|
42.1 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Inj. site Erythema, Post-Inj. 2
|
9.4 Percentage of participants
|
5.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Inj. site Swelling, Post-Inj. 2
|
4.7 Percentage of participants
|
3.9 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Injection site Pain, Post- Inj. 2
|
29.4 Percentage of participants
|
44.4 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Inj. site Erythema, Post- Inj. 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Inj. site Swelling, Post-Inj. 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Injection site Pain, Post- Inj. 2
|
38.3 Percentage of participants
|
62.8 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Inj. site Erythema, Post- Inj. 2
|
1.4 Percentage of participants
|
12.8 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Inj. site Swelling, Post-Inj. 2
|
0.2 Percentage of participants
|
4.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Injection site Pain, Post- Inj. 3
|
32.6 Percentage of participants
|
34.2 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Inj. site Erythema, Post-Inj. 3
|
8.2 Percentage of participants
|
6.6 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Inj. site Swelling, Post-Inj. 3
|
6.4 Percentage of participants
|
2.6 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Injection site Pain, Post- Inj. 3
|
26.7 Percentage of participants
|
38.6 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Inj. site Erythema, Post- Inj. 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Inj. site Swelling, Post-Inj. 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Injection site Pain, Post- Inj. 3
|
38.5 Percentage of participants
|
60.8 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Inj. site Erythema, Post- Inj. 3
|
2.8 Percentage of participants
|
13.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Inj. site Swelling, Post-Inj. 3
|
1.5 Percentage of participants
|
8.9 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Fever, Post-Inj. 1
|
8.1 Percentage of participants
|
6.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Headache, Post-Inj. 1
|
25.0 Percentage of participants
|
16.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Malaise, Post-Inj. 1
|
19.9 Percentage of participants
|
13.8 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Myalgia, Post-Inj. 1
|
23.7 Percentage of participants
|
16.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Asthenia, Post-Inj. 1
|
7.2 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Fever, Post-Inj. 1
|
7.1 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Headache, Post-Inj. 1
|
39.3 Percentage of participants
|
39.1 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Malaise, Post-Inj. 1
|
29.3 Percentage of participants
|
17.4 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Myalgia, Post-Inj. 1
|
32.1 Percentage of participants
|
23.9 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Asthenia, Post-Inj. 1
|
13.6 Percentage of participants
|
6.5 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Malaise, Post-Inj. 1
|
26.2 Percentage of participants
|
20.5 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Fever, Post-Inj. 1
|
2.3 Percentage of participants
|
1.2 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Myalgia, Post-Inj. 1
|
31.3 Percentage of participants
|
19.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Asthenia, Post-Inj. 1
|
15.1 Percentage of participants
|
7.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Fever, Post-Inj. 2
|
6.8 Percentage of participants
|
6.6 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Headache, Post-Inj. 2
|
21.7 Percentage of participants
|
15.8 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Malaise, Post-Inj. 2
|
21.7 Percentage of participants
|
13.2 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Myalgia, Post-Inj. 2
|
24.7 Percentage of participants
|
22.4 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Asthenia, Post-Inj. 2
|
7.7 Percentage of participants
|
7.9 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Fever, Post-Inj. 2
|
4.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Headache, Post-Inj. 2
|
19.9 Percentage of participants
|
22.2 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Malaise, Post-Inj. 2
|
16.2 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Myalgia, Post-Inj. 2
|
19.9 Percentage of participants
|
28.9 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Asthenia, Post-Inj. 2
|
8.8 Percentage of participants
|
6.7 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Fever, Post-Inj. 2
|
1.2 Percentage of participants
|
1.8 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Headache, Post-Inj. 2
|
24.2 Percentage of participants
|
24.4 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Malaise, Post-Inj. 2
|
18.6 Percentage of participants
|
20.1 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Myalgia, Post-Inj. 2
|
24.8 Percentage of participants
|
32.9 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Asthenia, Post-Inj. 2
|
10.2 Percentage of participants
|
12.2 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Fever, Post-Inj. 3
|
8.2 Percentage of participants
|
6.6 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Headache, Post-Inj. 3
|
17.6 Percentage of participants
|
11.8 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Malaise, Post-Inj. 3
|
18.5 Percentage of participants
|
14.5 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Myalgia, Post-Inj. 3
|
20.6 Percentage of participants
|
17.1 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
2-11 years; Asthenia, Post-Inj. 3
|
7.7 Percentage of participants
|
3.9 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Fever, Post-Inj. 3
|
5.9 Percentage of participants
|
2.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Headache, Post-Inj. 3
|
20.7 Percentage of participants
|
20.5 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Malaise, Post-Inj. 3
|
18.5 Percentage of participants
|
18.2 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Myalgia, Post-Inj. 3
|
14.8 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
12-17 years; Asthenia, Post-Inj. 3
|
5.9 Percentage of participants
|
11.4 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Fever, Post-Inj. 3
|
2.8 Percentage of participants
|
1.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Headache, Post-Inj. 3
|
21.2 Percentage of participants
|
23.4 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Malaise, Post-Inj. 3
|
17.9 Percentage of participants
|
18.4 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Myalgia, Post-Inj. 3
|
24.4 Percentage of participants
|
31.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
18-45 years; Asthenia, Post-Inj. 3
|
9.6 Percentage of participants
|
11.4 Percentage of participants
|
PRIMARY outcome
Timeframe: Pre-Injection 1, 2, and 3 and 28 days Post-Injection 1, 2, and 3Population: Analysis was performed on Per-Protocol (PP) analysis set which included all participants who were vaccinated and had no protocol deviations. Here, 'number analyzed' = participants with available data for each specified category.
Seropositivity against each dengue virus serotype (parental strains) was assessed using a dengue plaque reduction neutralization test (PRNT) assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=424 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=140 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Post-Injection 2
|
87.4 Percentage of participants
|
26.7 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Pre-Injection 3
|
77.8 Percentage of participants
|
19.0 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Post-Injection 3
|
93.2 Percentage of participants
|
24.8 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Pre-Injection 1
|
12.8 Percentage of participants
|
12.9 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Post-Injection 1
|
67.3 Percentage of participants
|
11.6 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Pre-Injection 2
|
69.1 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Post-Injection 2
|
85.8 Percentage of participants
|
16.9 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Pre-Injection 3
|
79.3 Percentage of participants
|
8.6 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Post-Injection 3
|
93.7 Percentage of participants
|
19.3 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Pre-Injection 1
|
14.6 Percentage of participants
|
17.1 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Post-Injection 1
|
22.9 Percentage of participants
|
11.6 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Pre-Injection 2
|
30.1 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Post-Injection 2
|
54.9 Percentage of participants
|
18.3 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Pre-Injection 3
|
45.8 Percentage of participants
|
13.8 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Post-Injection 3
|
79.6 Percentage of participants
|
22.0 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Pre-Injection 1
|
16.1 Percentage of participants
|
15.0 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Post-Injection 1
|
39.5 Percentage of participants
|
10.1 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Pre-Injection 2
|
39.3 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Post-Injection 2
|
80.4 Percentage of participants
|
15.0 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Pre-Injection 3
|
58.3 Percentage of participants
|
13.8 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Post-Injection 3
|
88.1 Percentage of participants
|
20.2 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Pre-Injection 1
|
19.7 Percentage of participants
|
20.1 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Post-Injection 1
|
58.7 Percentage of participants
|
21.7 Percentage of participants
|
|
Percentage of All Participants Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Pre-Injection 2
|
63.9 Percentage of participants
|
31.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Pre-Injection 1 and 28 days Post-Injection 3Population: Analysis was performed on Per-Protocol analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Seropositivity against each dengue virus serotypes (parental strains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=148 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=47 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
2-11 years, CYD dengue Serotype 1; Pre-Inj. 1
|
4.7 Percentage of participants
|
8.5 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
2-11 years, CYD dengue Serotype 1; Post-Inj. 3
|
92.4 Percentage of participants
|
10.8 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
2-11 years, CYD dengue Serotype 2; Pre-Inj. 1
|
5.4 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
2-11 years, CYD dengue Serotype 2; Post-Inj. 3
|
93.9 Percentage of participants
|
16.2 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
2-11 years, CYD dengue Serotype 3; Pre-Inj. 1
|
11.6 Percentage of participants
|
10.6 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
2-11 years, CYD dengue Serotype 3; Post-Inj. 3
|
98.5 Percentage of participants
|
13.5 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
2-11 years, CYD dengue Serotype 4; Pre-Inj. 1
|
6.8 Percentage of participants
|
6.4 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
2-11 years, CYD dengue Serotype 4; Post-Inj. 3
|
96.9 Percentage of participants
|
18.9 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
12-17 years, CYD dengue Serotype 1; Pre-Inj. 1
|
5.7 Percentage of participants
|
4.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
12-17 years, CYD dengue Serotype 1; Post-Inj. 3
|
68.3 Percentage of participants
|
13.2 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
12-17 years, CYD dengue Serotype 2; Pre-Inj. 1
|
10.0 Percentage of participants
|
4.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
12-17 years, CYD dengue Serotype 2; Post-Inj. 3
|
87.0 Percentage of participants
|
10.5 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
12-17 years, CYD dengue Serotype 3; Pre-Inj. 1
|
11.5 Percentage of participants
|
10.9 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
12-17 years, CYD dengue Serotype 3; Post-Inj. 3
|
88.5 Percentage of participants
|
21.1 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
12-17 years, CYD dengue Serotype 4; Pre-Inj. 1
|
6.5 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
12-17 years, CYD dengue Serotype 4; Post-Inj. 3
|
91.1 Percentage of participants
|
10.5 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
18-45 years, CYD dengue Serotype 1; Pre-Inj. 1
|
34.6 Percentage of participants
|
38.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
18-45 years, CYD dengue Serotype 1; Post-Inj. 3
|
76.5 Percentage of participants
|
44.1 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
18-45 years, CYD dengue Serotype 2; Pre-Inj. 1
|
34.1 Percentage of participants
|
38.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
18-45 years, CYD dengue Serotype 2; Post-Inj. 3
|
81.6 Percentage of participants
|
35.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
18-45 years, CYD dengue Serotype 3; Pre-Inj. 1
|
37.0 Percentage of participants
|
39.1 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
18-45 years, CYD dengue Serotype 3; Post-Inj. 3
|
91.8 Percentage of participants
|
41.2 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
18-45 years, CYD dengue Serotype 4; Pre-Inj. 1
|
26.1 Percentage of participants
|
30.4 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
18-45 years, CYD dengue Serotype 4; Post-Inj. 3
|
92.8 Percentage of participants
|
29.4 Percentage of participants
|
PRIMARY outcome
Timeframe: Pre-Injection 1 and 28 days Post-Injection 3Population: Analysis was performed on Per-Protocol analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes (parental strains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=148 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=47 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
2-11 yrs, CYD dengue >=1 serotype; Pre- Inj. 1
|
19.6 Percentage of participants
|
27.7 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
2-11 yrs, CYD dengue >=1 serotype; Post-Inj. 3
|
100 Percentage of participants
|
56.8 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
2-11 yrs, CYD dengue >=2 serotypes; Pre-Inj. 1
|
6.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
2-11 yrs, CYD dengue >=2 serotypes; Post-Inj. 3
|
99.2 Percentage of participants
|
2.7 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
2-11 yrs, CYD dengue >=3 serotypes; Pre-Inj. 1
|
2.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
2-11 yrs, CYD dengue >=3 serotypes; Post-Inj. 3
|
97.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
2-11 yrs, CYD dengue All 4 serotypes; Pre-Inj. 1
|
0.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
2-11 yrs, CYD dengue All 4 serotypes; Post-Inj. 3
|
84.8 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
12-17 yrs, CYD dengue >=1 serotype; Pre-Inj. 1
|
13.6 Percentage of participants
|
15.2 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
12-17 yrs, CYD dengue >=1 serotype; Post-Inj. 3
|
98.4 Percentage of participants
|
26.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
12-17 yrs, CYD dengue >=2 serotypes; Pre-Inj. 1
|
7.9 Percentage of participants
|
4.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
12-17 yrs, CYD dengue >=2 serotypes; Post-Inj. 3
|
95.1 Percentage of participants
|
10.5 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
12-17 yrs, CYD dengue >=3 serotypes; Pre-Inj. 1
|
7.1 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
12-17 yrs, CYD dengue >=3 serotypes; Post-Inj. 3
|
81.3 Percentage of participants
|
10.5 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
12-17 yrs, CYD dengue All 4 serotypes; Pre-Inj. 1
|
5.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
12-17 yrs, CYD dengue All 4 serotypes; Post-Inj. 3
|
59.3 Percentage of participants
|
7.9 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
18-45 yrs, CYD dengue >=1 serotype; Pre-Inj. 1
|
47.1 Percentage of participants
|
53.2 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
18-45 yrs, CYD dengue >=1 serotype; Post-Inj. 3
|
100 Percentage of participants
|
55.9 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
18-45 yrs, CYD dengue >=2 serotypes; Pre-Inj. 1
|
33.8 Percentage of participants
|
38.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
18-45 yrs, CYD dengue >=2 serotypes; Post-Inj. 3
|
96.9 Percentage of participants
|
35.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
18-45 yrs, CYD dengue >=3 serotypes; Pre-Inj. 1
|
27.9 Percentage of participants
|
31.9 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
18-45 yrs, CYD dengue >=3 serotypes; Post-Inj. 3
|
83.7 Percentage of participants
|
32.4 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
18-45 yrs, CYD dengue All 4 serotypes; Pre-Inj. 1
|
22.1 Percentage of participants
|
21.3 Percentage of participants
|
|
Percentage of Participants by Age Group (2-11 Years, 12-17 Years, 18-45 Years) Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
18-45 yrs, CYD dengue All 4 serotypes; Post-Inj. 3
|
61.2 Percentage of participants
|
26.5 Percentage of participants
|
PRIMARY outcome
Timeframe: Pre-Injection 1, 2, and 3 and 28 days Post-Injection 1, 2, and 3Population: Analysis was performed on Per-Protocol analysis set. Here, 'number analyzed' = participants with available data for each specified category.
GMTs against each serotype with the parental dengue virus strains were assessed using a dengue PRNT assay.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=424 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=140 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Pre-Injection 3
|
39.1 Titers (1/dilution)
Interval 31.2 to 48.9
|
8.23 Titers (1/dilution)
Interval 5.88 to 11.5
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Post-Injection 3
|
100 Titers (1/dilution)
Interval 86.9 to 116.0
|
9.52 Titers (1/dilution)
Interval 7.41 to 12.2
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Pre-Injection 1
|
6.93 Titers (1/dilution)
Interval 6.31 to 7.6
|
6.84 Titers (1/dilution)
Interval 5.86 to 7.99
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Post-Injection 1
|
65.9 Titers (1/dilution)
Interval 49.1 to 88.3
|
6.31 Titers (1/dilution)
Interval 5.3 to 7.5
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Pre-Injection 2
|
47.5 Titers (1/dilution)
Interval 36.5 to 61.8
|
7.91 Titers (1/dilution)
Interval 5.91 to 10.6
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Post-Injection 2
|
90.2 Titers (1/dilution)
Interval 71.7 to 114.0
|
8.00 Titers (1/dilution)
Interval 5.89 to 10.9
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Pre-Injection 3
|
47.1 Titers (1/dilution)
Interval 37.9 to 58.5
|
6.04 Titers (1/dilution)
Interval 5.09 to 7.17
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Post-Injection 3
|
99.4 Titers (1/dilution)
Interval 87.4 to 113.0
|
7.66 Titers (1/dilution)
Interval 6.35 to 9.24
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Pre-Injection 1
|
8.20 Titers (1/dilution)
Interval 7.2 to 9.33
|
8.23 Titers (1/dilution)
Interval 6.62 to 10.2
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Post-Injection 1
|
10.0 Titers (1/dilution)
Interval 8.06 to 12.4
|
7.09 Titers (1/dilution)
Interval 5.48 to 9.18
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Pre-Injection 2
|
12.9 Titers (1/dilution)
Interval 9.89 to 16.7
|
7.85 Titers (1/dilution)
Interval 5.79 to 10.6
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Post-Injection 2
|
22.4 Titers (1/dilution)
Interval 17.1 to 29.3
|
7.91 Titers (1/dilution)
Interval 5.85 to 10.7
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Pre-Injection 3
|
18.0 Titers (1/dilution)
Interval 14.0 to 23.2
|
7.40 Titers (1/dilution)
Interval 5.54 to 9.88
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Post-Injection 3
|
46.6 Titers (1/dilution)
Interval 39.0 to 55.6
|
8.93 Titers (1/dilution)
Interval 7.08 to 11.3
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Pre-Injection 1
|
9.06 Titers (1/dilution)
Interval 7.86 to 10.4
|
8.48 Titers (1/dilution)
Interval 6.69 to 10.8
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Post-Injection 1
|
17.2 Titers (1/dilution)
Interval 13.3 to 22.2
|
7.39 Titers (1/dilution)
Interval 5.49 to 9.94
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Pre-Injection 2
|
19.1 Titers (1/dilution)
Interval 14.3 to 25.5
|
9.79 Titers (1/dilution)
Interval 6.45 to 14.9
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Post-Injection 2
|
50.3 Titers (1/dilution)
Interval 39.0 to 65.0
|
9.48 Titers (1/dilution)
Interval 6.22 to 14.4
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Pre-Injection 3
|
24.4 Titers (1/dilution)
Interval 19.2 to 31.1
|
6.98 Titers (1/dilution)
Interval 5.38 to 9.07
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Post-Injection 3
|
72.7 Titers (1/dilution)
Interval 61.6 to 85.8
|
8.88 Titers (1/dilution)
Interval 6.9 to 11.4
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Pre-Injection 1
|
8.45 Titers (1/dilution)
Interval 7.54 to 9.47
|
8.93 Titers (1/dilution)
Interval 7.11 to 11.2
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Post-Injection 1
|
28.2 Titers (1/dilution)
Interval 22.0 to 36.3
|
9.56 Titers (1/dilution)
Interval 6.72 to 13.6
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Pre-Injection 2
|
29.7 Titers (1/dilution)
Interval 23.2 to 38.0
|
11.1 Titers (1/dilution)
Interval 7.6 to 16.3
|
|
Geometric Mean Titers (GMTs) of Antibodies in All Participants Against Each Serotype With the Parental Dengue Virus Strain Before and Following Each Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Post-Injection 2
|
70.8 Titers (1/dilution)
Interval 56.8 to 88.2
|
10.5 Titers (1/dilution)
Interval 7.36 to 14.9
|
PRIMARY outcome
Timeframe: Pre-Injection 1 and 28 days Post-Injection 3Population: Analysis was performed on Per-Protocol analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
GMTs against each dengue virus serotype (parental strains) were assessed using a dengue PRNT assay.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=148 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=47 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
2-11 years, CYD dengue Serotype 1; Pre-Inj. 1
|
5.33 Titers (1/dilution)
Interval 5.08 to 5.6
|
5.44 Titers (1/dilution)
Interval 5.01 to 5.92
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
2-11 years, CYD dengue Serotype 1; Post-Inj. 3
|
60.7 Titers (1/dilution)
Interval 49.5 to 74.3
|
6.32 Titers (1/dilution)
Interval 4.92 to 8.13
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
2-11 years, CYD dengue Serotype 2; Pre-Inj. 1
|
5.85 Titers (1/dilution)
Interval 5.18 to 6.6
|
5.18 Titers (1/dilution)
Interval 4.82 to 5.57
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
2-11 years, CYD dengue Serotype 2; Post-Inj. 3
|
95.9 Titers (1/dilution)
Interval 76.7 to 120.0
|
6.09 Titers (1/dilution)
Interval 5.18 to 7.16
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
2-11 years, CYD dengue Serotype 3; Pre-Inj. 1
|
6.24 Titers (1/dilution)
Interval 5.57 to 6.99
|
6.02 Titers (1/dilution)
Interval 5.04 to 7.17
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
2-11 years, CYD dengue Serotype 3; Post-Inj. 3
|
138 Titers (1/dilution)
Interval 115.0 to 165.0
|
6.67 Titers (1/dilution)
Interval 5.11 to 8.71
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
2-11 years, CYD dengue Serotype 4; Pre-Inj. 1
|
5.64 Titers (1/dilution)
Interval 5.2 to 6.11
|
5.42 Titers (1/dilution)
Interval 4.92 to 5.97
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
2-11 years, CYD dengue Serotype 4; Post-Inj. 3
|
101 Titers (1/dilution)
Interval 84.6 to 122.0
|
6.92 Titers (1/dilution)
Interval 5.47 to 8.76
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
12-17 years, CYD dengue Serotype 1; Pre-Inj. 1
|
6.49 Titers (1/dilution)
Interval 5.31 to 7.92
|
5.47 Titers (1/dilution)
Interval 4.8 to 6.24
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
12-17 years, CYD dengue Serotype 1; Post-Inj. 3
|
28.9 Titers (1/dilution)
Interval 21.5 to 38.7
|
6.56 Titers (1/dilution)
Interval 5.14 to 8.37
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
12-17 years, CYD dengue Serotype 2; Pre-Inj. 1
|
7.47 Titers (1/dilution)
Interval 5.96 to 9.37
|
5.54 Titers (1/dilution)
Interval 4.69 to 6.56
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
12-17 years, CYD dengue Serotype 2; Post-Inj. 3
|
54.0 Titers (1/dilution)
Interval 41.1 to 70.9
|
6.35 Titers (1/dilution)
Interval 5.03 to 8.0
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
12-17 years, CYD dengue Serotype 3; Pre-Inj. 1
|
6.86 Titers (1/dilution)
Interval 5.82 to 8.09
|
6.83 Titers (1/dilution)
Interval 4.84 to 9.65
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
12-17 years, CYD dengue Serotype 3; Post-Inj. 3
|
74.1 Titers (1/dilution)
Interval 57.5 to 95.5
|
8.32 Titers (1/dilution)
Interval 5.57 to 12.4
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
12-17 years, CYD dengue Serotype 4; Pre-Inj. 1
|
5.83 Titers (1/dilution)
Interval 5.18 to 6.57
|
5.08 Titers (1/dilution)
Interval 4.92 to 5.23
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
12-17 years, CYD dengue Serotype 4; Post-Inj. 3
|
80.4 Titers (1/dilution)
Interval 64.2 to 101.0
|
6.68 Titers (1/dilution)
Interval 4.87 to 9.15
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
18-45 years, CYD dengue Serotype 1; Pre-Inj. 1
|
16.7 Titers (1/dilution)
Interval 12.2 to 22.8
|
18.5 Titers (1/dilution)
Interval 10.4 to 32.9
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
18-45 years, CYD dengue Serotype 1; Post-Inj. 3
|
59.5 Titers (1/dilution)
Interval 38.7 to 91.6
|
18.3 Titers (1/dilution)
Interval 10.2 to 33.0
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
18-45 years, CYD dengue Serotype 2; Pre-Inj. 1
|
17.8 Titers (1/dilution)
Interval 12.8 to 24.7
|
21.1 Titers (1/dilution)
Interval 11.3 to 39.2
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
18-45 years, CYD dengue Serotype 2; Post-Inj. 3
|
72.7 Titers (1/dilution)
Interval 49.4 to 107.0
|
19.5 Titers (1/dilution)
Interval 9.69 to 39.1
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
18-45 years, CYD dengue Serotype 3; Pre-Inj. 1
|
14.6 Titers (1/dilution)
Interval 11.2 to 19.0
|
17.5 Titers (1/dilution)
Interval 10.2 to 30.0
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
18-45 years, CYD dengue Serotype 3; Post-Inj. 3
|
94.9 Titers (1/dilution)
Interval 69.4 to 130.0
|
16.3 Titers (1/dilution)
Interval 9.06 to 29.4
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
18-45 years, CYD dengue Serotype 4; Pre-Inj. 1
|
10.4 Titers (1/dilution)
Interval 8.22 to 13.2
|
11.7 Titers (1/dilution)
Interval 7.65 to 17.9
|
|
GMTs of Antibodies by Age Groups (2-11 Years, 12-17 Years, 18-45 Years) Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
18-45 years, CYD dengue Serotype 4; Post-Inj. 3
|
127 Titers (1/dilution)
Interval 96.0 to 167.0
|
9.96 Titers (1/dilution)
Interval 6.47 to 15.3
|
SECONDARY outcome
Timeframe: Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)Population: Full analysis set included participants who received at least 1 dose of CYD dengue vaccine or Placebo, had at least 1 blood sample drawn and valid post-vaccination serology result. Here, 'overall number of participants analyzed'=participants evaluable for outcome measure and 'number analyzed'=participants with available data for specified category.
Seropositivity against each dengue virus serotypes (parental strains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=236 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=80 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Pre-Injection 1
|
4.7 Percentage of participants
|
8.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Post-Injection 3
|
91.0 Percentage of participants
|
8.9 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 1st year follow up
|
41.8 Percentage of participants
|
6.8 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 2nd year follow up
|
27.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 3rd year follow up
|
16.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 4th year follow up
|
9.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Pre-Injection 1
|
5.4 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Post-Injection 3
|
94.4 Percentage of participants
|
13.3 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 1st year follow up
|
59.6 Percentage of participants
|
8.9 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 2nd year follow up
|
52.1 Percentage of participants
|
11.6 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 3rd year follow up
|
34.3 Percentage of participants
|
7.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 4th year follow up
|
36.9 Percentage of participants
|
2.4 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Pre-Injection 1
|
11.6 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Post-Injection 3
|
97.9 Percentage of participants
|
13.6 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 1st year follow up
|
66.0 Percentage of participants
|
9.1 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 2nd year follow up
|
74.4 Percentage of participants
|
29.3 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 3rd year follow up
|
50.0 Percentage of participants
|
4.7 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 4th year follow up
|
37.7 Percentage of participants
|
2.4 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Pre-Injection 1
|
6.8 Percentage of participants
|
6.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Post-Injection 3
|
97.2 Percentage of participants
|
20.5 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 1st year follow up
|
75.2 Percentage of participants
|
4.7 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 2nd year follow up
|
72.9 Percentage of participants
|
4.7 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 3rd year follow up
|
60.6 Percentage of participants
|
7.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 4th year follow up
|
49.3 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Seropositivity against each dengue virus serotypes (parental stains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with antibody titers \>=10 (1/dilution).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=141 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=46 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Pre-Injection 1
|
5.7 Percentage of participants
|
4.3 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Post-Injection 3
|
67.4 Percentage of participants
|
11.6 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 1st year follow up
|
25.8 Percentage of participants
|
7.3 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 2nd year follow up
|
19.5 Percentage of participants
|
7.5 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 3rd year follow up
|
16.1 Percentage of participants
|
5.0 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 4th year follow up
|
11.9 Percentage of participants
|
5.4 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Pre-Injection 1
|
9.9 Percentage of participants
|
4.3 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Post-Injection 3
|
83.7 Percentage of participants
|
9.3 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 1st year follow up
|
44.3 Percentage of participants
|
4.9 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 2nd year follow up
|
52.3 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 3rd year follow up
|
35.5 Percentage of participants
|
5.0 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 4th year follow up
|
36.2 Percentage of participants
|
5.4 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Pre-Injection 1
|
11.4 Percentage of participants
|
10.9 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Post-Injection 3
|
88.8 Percentage of participants
|
20.9 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 1st year follow up
|
61.7 Percentage of participants
|
5.0 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 2nd year follow up
|
56.3 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 3rd year follow up
|
48.8 Percentage of participants
|
5.0 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 4th year follow up
|
47.5 Percentage of participants
|
5.4 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Pre-Injection 1
|
6.4 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Post-Injection 3
|
91.1 Percentage of participants
|
9.3 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 1st year follow up
|
73.5 Percentage of participants
|
2.4 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 2nd year follow up
|
71.1 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 3rd year follow up
|
66.7 Percentage of participants
|
5.0 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 4th year follow up
|
61.0 Percentage of participants
|
8.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Seropositivity against each dengue virus serotypes (parental stains) was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=521 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=174 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Pre-Injection 1
|
33.1 Percentage of participants
|
38.8 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Post-Injection 3
|
71.7 Percentage of participants
|
39.5 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 1st year follow up
|
45.9 Percentage of participants
|
31.8 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 2nd year follow up
|
43.6 Percentage of participants
|
34.1 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 3rd year follow up
|
40.4 Percentage of participants
|
30.8 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 4th year follow up
|
39.6 Percentage of participants
|
31.6 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Pre-Injection 1
|
32.6 Percentage of participants
|
38.8 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Post-Injection 3
|
80.3 Percentage of participants
|
30.2 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 1st year follow up
|
66.4 Percentage of participants
|
40.9 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 2nd year follow up
|
68.4 Percentage of participants
|
34.1 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 3rd year follow up
|
55.3 Percentage of participants
|
35.9 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 4th year follow up
|
55.2 Percentage of participants
|
31.6 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Pre-Injection 1
|
36.9 Percentage of participants
|
41.7 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Post-Injection 3
|
92.9 Percentage of participants
|
34.9 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 1st year follow up
|
68.6 Percentage of participants
|
38.6 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 2nd year follow up
|
77.8 Percentage of participants
|
46.3 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 3rd year follow up
|
67.9 Percentage of participants
|
35.9 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 4th year follow up
|
56.6 Percentage of participants
|
29.7 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Pre-Injection 1
|
25.0 Percentage of participants
|
31.3 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Post-Injection 3
|
93.7 Percentage of participants
|
32.6 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 1st year follow up
|
86.9 Percentage of participants
|
29.5 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 2nd year follow up
|
81.2 Percentage of participants
|
24.4 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 3rd year follow up
|
79.8 Percentage of participants
|
20.5 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Who Achieved Seropositivity Against Each of the Dengue Virus Serotypes Before and up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 4th year follow up
|
77.6 Percentage of participants
|
21.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=236 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=80 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=3 serotypes; 4th year follow up
|
16.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=1 serotype; Pre-Injection 1
|
19.6 Percentage of participants
|
26.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=1 serotype; Post-Injection 3
|
100.0 Percentage of participants
|
51.1 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=1 serotype; 1st year follow up
|
92.3 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=1 serotype; 2nd year follow up
|
95.0 Percentage of participants
|
34.9 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=1 serotype; 3rd year follow up
|
76.9 Percentage of participants
|
7.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=1 serotype; 4th year follow up
|
72.1 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=2 serotypes; Pre-Injection 1
|
6.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=2 serotypes; Post- Injection 3
|
99.3 Percentage of participants
|
4.4 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=2 serotypes; 1st year follow up
|
66.2 Percentage of participants
|
6.7 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=2 serotypes; 2nd year follow up
|
70.7 Percentage of participants
|
9.3 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=2 serotypes; 3rd year follow up
|
48.5 Percentage of participants
|
7.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=2 serotypes; 4th year follow up
|
35.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=3 serotypes; Pre-Injection 1
|
2.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=3 serotypes; Post- Injection 3
|
96.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=3 serotypes; 1st year follow up
|
52.8 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=3 serotypes; 2nd year follow up
|
42.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=3 serotypes; 3rd year follow up
|
23.9 Percentage of participants
|
4.7 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue All 4 serotypes; Pre- Injection 1
|
0.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue All 4 serotypes; Post- Injection 3
|
84.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue All 4 serotypes; 1st year follow up
|
29.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue All 4 serotypes; 2nd year follow up
|
15.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue All 4 serotypes; 3rd year follow up
|
11.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Aged 2 to 11 Years Old Who Achieved Seropositivity Against At Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue All 4 serotypes; 4th year follow up
|
6.6 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=141 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=46 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=3 Serotypes; 1st year follow up
|
33.1 Percentage of participants
|
4.9 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=1 Serotype; Pre-Injection 1
|
13.5 Percentage of participants
|
15.2 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=1 Serotype; Post- Injection 3
|
97.8 Percentage of participants
|
25.6 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=1 Serotype; 1st year follow up
|
94.7 Percentage of participants
|
7.3 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=1 Serotype; 2nd year follow up
|
93.0 Percentage of participants
|
15.0 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=1 Serotype; 3rd year follow up
|
89.5 Percentage of participants
|
5.0 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=1 serotype; 4th year follow up
|
81.4 Percentage of participants
|
8.1 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=2 Serotypes; Pre- Injection 1
|
7.8 Percentage of participants
|
4.3 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=2 Serotypes; Post- Injection 3
|
94.8 Percentage of participants
|
9.3 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=2 Serotypes; 1st year follow up
|
60.2 Percentage of participants
|
4.9 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=2 Serotypes; 2nd year follow up
|
62.5 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=2 Serotypes; 3rd year follow up
|
45.2 Percentage of participants
|
5.0 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=2 serotypes; 4th year follow up
|
44.9 Percentage of participants
|
5.4 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=3 Serotypes; Pre- Injection 1
|
7.1 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=3 Serotypes; Post- Injection 3
|
80.7 Percentage of participants
|
9.3 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=3 Serotypes; 2nd year follow up
|
31.3 Percentage of participants
|
7.5 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=3 Serotypes; 3rd year follow up
|
22.6 Percentage of participants
|
5.0 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=3 serotypes; 4th year follow up
|
20.3 Percentage of participants
|
5.4 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue All 4 Serotypes; Pre- Injection 1
|
5.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue All 4 Serotypes; Post- Injection 3
|
57.0 Percentage of participants
|
7.0 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue All 4 Serotypes; 1st year follow up
|
15.8 Percentage of participants
|
2.4 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue All 4 Serotypes; 2nd year follow up
|
11.7 Percentage of participants
|
7.5 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue All 4 Serotypes; 3rd year follow up
|
8.9 Percentage of participants
|
5.0 Percentage of participants
|
|
Percentage of Participants Aged 12 to 17 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue All 4 serotypes; 4th year follow up
|
9.3 Percentage of participants
|
5.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Seropositivity against at least 1, 2, 3, or 4 dengue virus serotypes was assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=521 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=174 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue All 4 Serotypes; Pre- Injection 1
|
21.1 Percentage of participants
|
22.4 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=1 Serotype; Pre-Injection 1
|
46.5 Percentage of participants
|
55.1 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=1 Serotype; Post- Injection 3
|
100.0 Percentage of participants
|
53.5 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=1 Serotype; 1st year follow up
|
96.7 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=1 Serotype; 2nd year follow up
|
96.6 Percentage of participants
|
56.1 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=1 Serotype; 3rd year follow up
|
93.0 Percentage of participants
|
41.0 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=1 serotype; 4th year follow up
|
92.5 Percentage of participants
|
36.8 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=2 Serotypes; Pre- Injection 1
|
32.4 Percentage of participants
|
38.8 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=2 Serotypes; Post- Injection 3
|
97.6 Percentage of participants
|
32.6 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=2 Serotypes; 1st year follow up
|
73.8 Percentage of participants
|
38.6 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=2 Serotypes; 2nd year follow up
|
76.9 Percentage of participants
|
34.1 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=2 Serotypes; 3rd year follow up
|
63.2 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=2 serotypes; 4th year follow up
|
54.2 Percentage of participants
|
28.9 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=3 Serotypes; Pre- Injection 1
|
26.8 Percentage of participants
|
32.7 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=3 Serotypes; Post- Injection 3
|
83.5 Percentage of participants
|
27.9 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=3 Serotypes; 1st year follow up
|
55.7 Percentage of participants
|
34.1 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=3 Serotypes; 2nd year follow up
|
56.4 Percentage of participants
|
29.3 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=3 Serotypes; 3rd year follow up
|
46.5 Percentage of participants
|
30.8 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue >=3 serotypes; 4th year follow up
|
43.0 Percentage of participants
|
26.3 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue All 4 Serotypes; Post- Injection 3
|
56.7 Percentage of participants
|
23.3 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue All 4 Serotypes; 1st year follow up
|
41.0 Percentage of participants
|
18.2 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue All 4 Serotypes; 2nd year follow up
|
41.0 Percentage of participants
|
19.5 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue All 4 Serotypes; 3rd year follow up
|
39.5 Percentage of participants
|
17.9 Percentage of participants
|
|
Percentage of Participants Aged 18 to 45 Years Old Who Achieved Seropositivity Against at Least 1, 2, 3, or 4 of the Dengue Virus Serotypes Before and After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue All 4 serotypes; 4th year follow up
|
37.4 Percentage of participants
|
21.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
GMTs against each serotype with the dengue virus strain (parental strains) were assessed using a dengue PRNT assay.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=236 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=80 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 1; Pre-Injection 1
|
5.33 Titers (1/dilution)
Interval 5.08 to 5.6
|
5.42 Titers (1/dilution)
Interval 5.0 to 5.86
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 1; Post-Injection 3
|
56.6 Titers (1/dilution)
Interval 46.5 to 68.9
|
6.06 Titers (1/dilution)
Interval 4.93 to 7.46
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 1; 1st year follow up
|
12.1 Titers (1/dilution)
Interval 9.92 to 14.7
|
5.52 Titers (1/dilution)
Interval 4.92 to 6.19
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 1; 2nd year follow up
|
8.89 Titers (1/dilution)
Interval 7.5 to 10.5
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 1; 3rd year follow up
|
7.35 Titers (1/dilution)
Interval 6.22 to 8.67
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 1; 4th year follow up
|
6.21 Titers (1/dilution)
Interval 5.51 to 7.0
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 2; Pre-Injection 1
|
5.85 Titers (1/dilution)
Interval 5.18 to 6.6
|
5.17 Titers (1/dilution)
Interval 4.83 to 5.53
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 2; Post-Injection 3
|
101 Titers (1/dilution)
Interval 81.7 to 125.0
|
5.88 Titers (1/dilution)
Interval 5.15 to 6.72
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 2; 1st year follow up
|
21.1 Titers (1/dilution)
Interval 16.6 to 26.9
|
5.86 Titers (1/dilution)
Interval 4.79 to 7.16
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 2; 2nd year follow up
|
16.4 Titers (1/dilution)
Interval 12.9 to 20.9
|
6.11 Titers (1/dilution)
Interval 5.1 to 7.32
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 2; 3rd year follow up
|
11.7 Titers (1/dilution)
Interval 9.1 to 15.1
|
5.58 Titers (1/dilution)
Interval 4.86 to 6.41
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 2; 4th year follow up
|
14.2 Titers (1/dilution)
Interval 10.7 to 19.0
|
5.11 Titers (1/dilution)
Interval 4.89 to 5.32
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 3; Pre-Injection 1
|
6.24 Titers (1/dilution)
Interval 5.57 to 6.99
|
5.95 Titers (1/dilution)
Interval 5.04 to 7.02
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 3; Post-Injection 3
|
136 Titers (1/dilution)
Interval 114.0 to 162.0
|
6.54 Titers (1/dilution)
Interval 5.2 to 8.22
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 3; 1st year follow up
|
25.4 Titers (1/dilution)
Interval 20.1 to 32.1
|
5.87 Titers (1/dilution)
Interval 5.0 to 6.89
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 3; 2nd year follow up
|
29.9 Titers (1/dilution)
Interval 23.4 to 38.1
|
10.1 Titers (1/dilution)
Interval 6.68 to 15.2
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 3; 3rd year follow up
|
14.6 Titers (1/dilution)
Interval 11.7 to 18.3
|
5.43 Titers (1/dilution)
Interval 4.83 to 6.1
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 3; 4th year follow up
|
11.4 Titers (1/dilution)
Interval 9.22 to 14.1
|
5.09 Titers (1/dilution)
Interval 4.91 to 5.29
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 4; Pre-Injection 1
|
5.64 Titers (1/dilution)
Interval 5.2 to 6.11
|
5.39 Titers (1/dilution)
Interval 4.92 to 5.91
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 4; Post-Injection 3
|
104 Titers (1/dilution)
Interval 87.2 to 125.0
|
7.20 Titers (1/dilution)
Interval 5.74 to 9.05
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 4; 1st year follow up
|
31.8 Titers (1/dilution)
Interval 25.6 to 39.6
|
5.69 Titers (1/dilution)
Interval 4.7 to 6.89
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 4; 2nd year follow up
|
30.6 Titers (1/dilution)
Interval 24.2 to 38.6
|
5.68 Titers (1/dilution)
Interval 4.74 to 6.82
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 4; 3rd year follow up
|
22.3 Titers (1/dilution)
Interval 17.5 to 28.5
|
6.31 Titers (1/dilution)
Interval 4.84 to 8.24
|
|
GMTs of Antibodies in Participants 2 to 11 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine
CYD dengue Serotype 4; 4th year follow up
|
16.5 Titers (1/dilution)
Interval 13.1 to 20.7
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
SECONDARY outcome
Timeframe: Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
GMTs against each serotype with the dengue virus strain (parental strains) were assessed using a dengue PRNT assay.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=141 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=46 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Pre-Injection 1
|
6.47 Titers (1/dilution)
Interval 5.31 to 7.89
|
5.47 Titers (1/dilution)
Interval 4.8 to 6.24
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Post-Injection 3
|
28.5 Titers (1/dilution)
Interval 21.4 to 37.9
|
6.36 Titers (1/dilution)
Interval 5.12 to 7.89
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 1st year follow up
|
9.69 Titers (1/dilution)
Interval 7.53 to 12.5
|
5.69 Titers (1/dilution)
Interval 4.88 to 6.63
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 2nd year follow up
|
8.31 Titers (1/dilution)
Interval 6.58 to 10.5
|
5.91 Titers (1/dilution)
Interval 4.8 to 7.27
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 3rd year follow up
|
8.02 Titers (1/dilution)
Interval 6.3 to 10.2
|
5.54 Titers (1/dilution)
Interval 4.79 to 6.39
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 4th year follow up
|
7.41 Titers (1/dilution)
Interval 5.85 to 9.38
|
5.51 Titers (1/dilution)
Interval 4.8 to 6.34
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Pre-Injection 1
|
7.45 Titers (1/dilution)
Interval 5.95 to 9.33
|
5.54 Titers (1/dilution)
Interval 4.69 to 6.56
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Post-Injection 3
|
48.7 Titers (1/dilution)
Interval 37.4 to 63.5
|
6.17 Titers (1/dilution)
Interval 5.03 to 7.58
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 1st year follow up
|
16.6 Titers (1/dilution)
Interval 12.4 to 22.1
|
5.58 Titers (1/dilution)
Interval 4.78 to 6.52
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 2nd year follow up
|
18.7 Titers (1/dilution)
Interval 14.1 to 24.7
|
6.38 Titers (1/dilution)
Interval 4.92 to 8.27
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 3rd year follow up
|
13.3 Titers (1/dilution)
Interval 10.1 to 17.6
|
5.77 Titers (1/dilution)
Interval 4.71 to 7.07
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 4th year follow up
|
14.0 Titers (1/dilution)
Interval 10.4 to 18.8
|
5.80 Titers (1/dilution)
Interval 4.68 to 7.17
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Pre-Injection 1
|
6.84 Titers (1/dilution)
Interval 5.81 to 8.06
|
6.83 Titers (1/dilution)
Interval 4.84 to 9.65
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Post-Injection 3
|
71.4 Titers (1/dilution)
Interval 56.3 to 90.7
|
8.10 Titers (1/dilution)
Interval 5.66 to 11.6
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 1st year follow up
|
19.7 Titers (1/dilution)
Interval 15.1 to 25.6
|
6.27 Titers (1/dilution)
Interval 4.55 to 8.64
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 2nd year follow up
|
20.5 Titers (1/dilution)
Interval 15.6 to 27.1
|
7.54 Titers (1/dilution)
Interval 5.16 to 11.0
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 3rd year follow up
|
15.3 Titers (1/dilution)
Interval 11.8 to 19.9
|
6.17 Titers (1/dilution)
Interval 4.58 to 8.31
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 4th year follow up
|
13.7 Titers (1/dilution)
Interval 10.7 to 17.6
|
6.47 Titers (1/dilution)
Interval 4.49 to 9.3
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Pre-Injection 1
|
5.83 Titers (1/dilution)
Interval 5.17 to 6.56
|
5.08 Titers (1/dilution)
Interval 4.92 to 5.23
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Post-Injection 3
|
79.2 Titers (1/dilution)
Interval 64.2 to 97.8
|
6.45 Titers (1/dilution)
Interval 4.89 to 8.53
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 1st year follow up
|
30.8 Titers (1/dilution)
Interval 24.3 to 39.0
|
5.17 Titers (1/dilution)
Interval 4.84 to 5.52
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 2nd year follow up
|
33.4 Titers (1/dilution)
Interval 25.6 to 43.6
|
6.18 Titers (1/dilution)
Interval 4.99 to 7.65
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 3rd year follow up
|
23.1 Titers (1/dilution)
Interval 18.3 to 29.2
|
5.55 Titers (1/dilution)
Interval 4.79 to 6.42
|
|
GMTs of Antibodies in Participants 12 to 17 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 4th year follow up
|
20.8 Titers (1/dilution)
Interval 16.2 to 26.6
|
5.43 Titers (1/dilution)
Interval 4.92 to 6.0
|
SECONDARY outcome
Timeframe: Pre-Injection 1, 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
GMTs against each serotype with the dengue virus strain were assessed using a dengue PRNT assay.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=521 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=174 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Post-Injection 3
|
122 Titers (1/dilution)
Interval 96.5 to 155.0
|
10.0 Titers (1/dilution)
Interval 6.96 to 14.4
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Pre-Injection 1
|
15.8 Titers (1/dilution)
Interval 11.7 to 21.5
|
19.2 Titers (1/dilution)
Interval 10.9 to 33.9
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Post-Injection 3
|
48.7 Titers (1/dilution)
Interval 33.6 to 70.4
|
16.2 Titers (1/dilution)
Interval 9.77 to 27.0
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 1st year follow up
|
26.3 Titers (1/dilution)
Interval 17.9 to 38.6
|
15.2 Titers (1/dilution)
Interval 8.76 to 26.3
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 2nd year follow up
|
26.3 Titers (1/dilution)
Interval 17.7 to 38.9
|
16.3 Titers (1/dilution)
Interval 9.09 to 29.3
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 3rd year follow up
|
24.1 Titers (1/dilution)
Interval 15.9 to 36.5
|
13.9 Titers (1/dilution)
Interval 7.89 to 24.6
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 4th year follow up
|
23.5 Titers (1/dilution)
Interval 15.5 to 35.5
|
14.4 Titers (1/dilution)
Interval 8.03 to 25.6
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Pre-Injection 1
|
16.9 Titers (1/dilution)
Interval 12.3 to 23.1
|
21.0 Titers (1/dilution)
Interval 11.5 to 38.2
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Post-Injection 3
|
66.9 Titers (1/dilution)
Interval 47.9 to 93.5
|
15.2 Titers (1/dilution)
Interval 8.61 to 27.0
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 1st year follow up
|
50.4 Titers (1/dilution)
Interval 34.5 to 73.7
|
19.3 Titers (1/dilution)
Interval 10.7 to 34.7
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 2nd year follow up
|
66.5 Titers (1/dilution)
Interval 43.7 to 101.0
|
20.0 Titers (1/dilution)
Interval 10.2 to 39.0
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 3rd year follow up
|
38.4 Titers (1/dilution)
Interval 25.8 to 57.2
|
17.0 Titers (1/dilution)
Interval 9.38 to 30.8
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 4th year follow up
|
32.9 Titers (1/dilution)
Interval 22.4 to 48.2
|
15.5 Titers (1/dilution)
Interval 8.51 to 28.2
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Pre-Injection 1
|
14.5 Titers (1/dilution)
Interval 11.2 to 18.7
|
19.4 Titers (1/dilution)
Interval 11.4 to 33.1
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Post-Injection 3
|
88.4 Titers (1/dilution)
Interval 68.6 to 114.0
|
13.3 Titers (1/dilution)
Interval 8.22 to 21.7
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 1st year follow up
|
45.2 Titers (1/dilution)
Interval 32.1 to 63.6
|
14.8 Titers (1/dilution)
Interval 8.96 to 24.3
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 2nd year follow up
|
64.8 Titers (1/dilution)
Interval 46.8 to 89.7
|
19.9 Titers (1/dilution)
Interval 11.5 to 34.5
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 3rd year follow up
|
48.3 Titers (1/dilution)
Interval 33.0 to 70.8
|
14.7 Titers (1/dilution)
Interval 8.46 to 25.7
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 4th year follow up
|
28.6 Titers (1/dilution)
Interval 20.2 to 40.6
|
11.8 Titers (1/dilution)
Interval 7.18 to 19.3
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Pre-Injection 1
|
10.1 Titers (1/dilution)
Interval 8.03 to 12.7
|
11.7 Titers (1/dilution)
Interval 7.74 to 17.6
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 1st year follow up
|
70.3 Titers (1/dilution)
Interval 53.6 to 92.2
|
9.87 Titers (1/dilution)
Interval 6.88 to 14.2
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 2nd year follow up
|
52.6 Titers (1/dilution)
Interval 39.9 to 69.3
|
8.50 Titers (1/dilution)
Interval 6.07 to 11.9
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 3rd year follow up
|
46.4 Titers (1/dilution)
Interval 35.5 to 60.6
|
8.39 Titers (1/dilution)
Interval 5.83 to 12.1
|
|
GMTs of Antibodies in Participants 18 to 45 Years Old Against Each Serotype With the Parental Dengue Virus Strain Before and Following the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 4th year follow up
|
32.6 Titers (1/dilution)
Interval 25.2 to 42.3
|
7.54 Titers (1/dilution)
Interval 5.69 to 10.0
|
SECONDARY outcome
Timeframe: 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with antibody titers \>=10 (1/dilution). Dengue participants immune at baseline was defined as those participants with titers \>=10 (1/dilution) against at least one dengue serotype at baseline.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=29 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=13 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 3rd year follow up
|
70.4 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Post-Injection 3
|
96.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 1st year follow up
|
74.1 Percentage of participants
|
7.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 2nd year follow up
|
55.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 3rd year follow up
|
33.3 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 4th year follow up
|
22.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Post-Injection 3
|
100.0 Percentage of participants
|
15.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 1st year follow up
|
85.2 Percentage of participants
|
15.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 2nd year follow up
|
66.7 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 3rd year follow up
|
48.1 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 4th year follow up
|
48.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Post-Injection 3
|
100.0 Percentage of participants
|
23.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 1st year follow up
|
88.9 Percentage of participants
|
7.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 2nd year follow up
|
81.5 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 3rd year follow up
|
59.3 Percentage of participants
|
8.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 4th year follow up
|
50.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Post-Injection 3
|
100.0 Percentage of participants
|
23.1 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 1st year follow up
|
88.9 Percentage of participants
|
15.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 2nd year follow up
|
74.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 4th year follow up
|
70.4 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). Dengue participants naïve at baseline was defined as those participants with titers \<10 (1/dilution) against all dengue serotypes at baseline.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=118 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=37 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Post-Injection 3
|
89.6 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 1st year follow up
|
33.6 Percentage of participants
|
6.5 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 2nd year follow up
|
20.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 3rd year follow up
|
12.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 4th year follow up
|
6.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Post-Injection 3
|
93.0 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 1st year follow up
|
54.0 Percentage of participants
|
6.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 2nd year follow up
|
49.1 Percentage of participants
|
9.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 3rd year follow up
|
31.1 Percentage of participants
|
3.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 4th year follow up
|
34.3 Percentage of participants
|
3.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Post-Injection 3
|
97.4 Percentage of participants
|
9.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 1st year follow up
|
60.2 Percentage of participants
|
9.7 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 2nd year follow up
|
72.4 Percentage of participants
|
34.5 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 3rd year follow up
|
47.2 Percentage of participants
|
3.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 4th year follow up
|
34.3 Percentage of participants
|
3.3 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Post-Injection 3
|
96.5 Percentage of participants
|
19.4 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 1st year follow
|
71.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 2nd year follow up
|
73.2 Percentage of participants
|
6.5 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 3rd year follow up
|
58.7 Percentage of participants
|
3.2 Percentage of participants
|
|
Percentage of Participants (Aged 2 to 11 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 4th year follow up
|
44.4 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). Dengue participants immune at baseline was defined as those participants with titers \>=10 (1/dilution) against at least one dengue serotype at baseline.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=19 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=7 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Post-Injection 3
|
94.4 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 1st year follow up
|
58.8 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 2nd year follow up
|
46.7 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 3rd year follow up
|
43.8 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 4th year follow up
|
42.9 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Post-Injection 3
|
94.4 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 1st year follow up
|
82.4 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 2nd year follow up
|
73.3 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 3rd year follow up
|
68.8 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 4th year follow up
|
71.4 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Post-Injection 3
|
100.0 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 1st year follow up
|
76.5 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 2nd year follow up
|
80.0 Percentage of participants
|
50.0 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 3rd year follow up
|
68.8 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 4th year follow up
|
71.4 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Post-Injection 3
|
100.0 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 1st year follow up
|
100.0 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 2nd year follow up
|
100.0 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 3rd year follow up
|
93.8 Percentage of participants
|
16.7 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 4th year follow up
|
100.0 Percentage of participants
|
20.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Seropositivity against each serotype with the dengue virus strain were assessed using a PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). Dengue participants naïve at baseline was defined as those participants with titers \<10 (1/dilution) against all dengue serotypes at baseline.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=121 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=39 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 1st year follow up
|
69.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 2nd year follow up
|
67.0 Percentage of participants
|
8.8 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 3rd year follow up
|
62.6 Percentage of participants
|
2.9 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Post-Injection 3
|
62.9 Percentage of participants
|
8.1 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 1st year follow up
|
20.9 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 2nd year follow up
|
16.1 Percentage of participants
|
5.9 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 3rd year follow up
|
12.0 Percentage of participants
|
2.9 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 4th year follow up
|
7.7 Percentage of participants
|
3.1 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Post-Injection 3
|
81.9 Percentage of participants
|
8.1 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 1st year follow up
|
38.6 Percentage of participants
|
2.8 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 2nd year follow up
|
49.1 Percentage of participants
|
5.9 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 3rd year follow up
|
30.6 Percentage of participants
|
2.9 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 4th year follow up
|
31.4 Percentage of participants
|
3.1 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Post-Injection 3
|
87.0 Percentage of participants
|
16.2 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 1st year follow up
|
59.5 Percentage of participants
|
2.9 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 2nd year follow up
|
53.6 Percentage of participants
|
5.9 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 3rd year follow up
|
45.8 Percentage of participants
|
2.9 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 4th year follow up
|
44.2 Percentage of participants
|
3.1 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 4th year follow up
|
55.8 Percentage of participants
|
6.3 Percentage of participants
|
|
Percentage of Participants (Aged 12 to 17 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Post-Injection 3
|
89.7 Percentage of participants
|
5.4 Percentage of participants
|
SECONDARY outcome
Timeframe: 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). Dengue participants immune at baseline was defined as those participants with titers \>=10 (1/dilution) against at least one dengue serotype at baseline.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=66 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=27 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Post-Injection 3
|
89.3 Percentage of participants
|
70.0 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 1st year follow up
|
77.8 Percentage of participants
|
57.1 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 2nd year follow up
|
86.3 Percentage of participants
|
65.0 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 1st year follow up
|
88.9 Percentage of participants
|
71.4 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 3rd year follow up
|
80.8 Percentage of participants
|
63.2 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 4th year follow up
|
84.8 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Post-Injection 3
|
91.1 Percentage of participants
|
65.0 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 2nd year follow up
|
92.2 Percentage of participants
|
70.0 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 3rd year follow up
|
88.5 Percentage of participants
|
68.4 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 4th year follow up
|
91.5 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Post-Injection 3
|
98.2 Percentage of participants
|
60.0 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 1st year follow up
|
90.7 Percentage of participants
|
66.7 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 2nd year follow up
|
98.0 Percentage of participants
|
70.0 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 3rd year follow up
|
94.2 Percentage of participants
|
73.7 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 4th year follow up
|
91.5 Percentage of participants
|
61.1 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Post-Injection 3
|
100.0 Percentage of participants
|
65.0 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 1st year follow up
|
98.1 Percentage of participants
|
47.6 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 2nd year follow up
|
96.1 Percentage of participants
|
45.0 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 3rd year follow up
|
100.0 Percentage of participants
|
42.1 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Immune to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 4th year follow up
|
97.9 Percentage of participants
|
44.4 Percentage of participants
|
SECONDARY outcome
Timeframe: 28 days Post-Injection 3, at 1 year follow up, 2 year follow up, 3 year follow up and 4 year follow up (assessed post-injection 3 during the follow up duration of 4 years)Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Seropositivity against each serotype with the dengue virus strain were assessed using a dengue PRNT assay. Seropositive participants were defined as participants with neutralizing antibody titers \>=10 (1/dilution). Dengue participants naïve at baseline was defined as those participants with titers \<10 (1/dilution) against all dengue serotypes at baseline.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=74 Participants
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=22 Participants
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; Post-Injection 3
|
59.4 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 1st year follow up
|
21.3 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 2nd year follow up
|
10.2 Percentage of participants
|
5.3 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 3rd year follow up
|
7.1 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 1; 4th year follow up
|
5.6 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; Post-Injection 3
|
73.4 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 1st year follow up
|
49.2 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 2nd year follow up
|
50.8 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 3rd year follow up
|
28.6 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 2; 4th year follow up
|
26.4 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; Post-Injection 3
|
87.5 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 1st year follow up
|
48.3 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 2nd year follow up
|
61.0 Percentage of participants
|
21.1 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 3rd year follow up
|
46.3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 3; 4th year follow up
|
28.3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; Post-Injection 3
|
87.5 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 1st year follow up
|
78.7 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 2nd year follow up
|
71.2 Percentage of participants
|
5.3 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 3rd year follow up
|
66.1 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants (Aged 18 to 45 Years) Naïve to Dengue at Baseline Who Are Seropositive for Each of the Dengue Virus Serotypes up to 4 Years After the Third Vaccination With CYD Dengue Vaccine or Placebo
CYD dengue Serotype 4; 4th year follow up
|
63.0 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
CYD Dengue Vaccine Group
Serious events: 43 serious events
Other events: 481 other events
Deaths: 3 deaths
Placebo Group
Serious events: 13 serious events
Other events: 198 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CYD Dengue Vaccine Group
n=898 participants at risk
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=300 participants at risk
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Surgical and medical procedures
Osteotomy
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/898 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.33%
1/300 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/898 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.33%
1/300 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
General disorders
Adverse drug reaction
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
General disorders
Chest pain
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Psychiatric disorders
Depression
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/898 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.33%
1/300 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/898 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.33%
1/300 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/898 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.33%
1/300 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/898 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.33%
1/300 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.22%
2/898 • Number of events 2 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.33%
1/300 • Number of events 2 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Nervous system disorders
Migraine
|
0.22%
2/898 • Number of events 2 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Nervous system disorders
Radial nerve palsy
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Nervous system disorders
Syncope vasovagal
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Nervous system disorders
Tension headache
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.33%
1/300 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Gastrointestinal disorders
Colitis
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Gastrointestinal disorders
Gingivitis
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/898 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.33%
1/300 • Number of events 2 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/898 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.33%
1/300 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Endocrine disorders
Hyperthyroidism
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Endocrine disorders
Thyroid disorder
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Appendicitis
|
0.22%
2/898 • Number of events 2 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Bronchitis
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Conjunctivitis viral
|
0.22%
2/898 • Number of events 2 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Corneal infection
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Dengue fever
|
0.33%
3/898 • Number of events 3 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Gastroenteritis
|
0.22%
2/898 • Number of events 3 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.33%
1/300 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Gastroenteritis viral
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.67%
2/300 • Number of events 2 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Groin abscess
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.22%
2/898 • Number of events 2 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Herpangina
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Lymph node tuberculosis
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/898 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.33%
1/300 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Pharyngitis
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.33%
1/300 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Pharyngitis bacterial
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Subcutaneous abscess
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.33%
1/300 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.22%
2/898 • Number of events 2 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Viral infection
|
0.11%
1/898 • Number of events 1 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
0.00%
0/300 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
Other adverse events
| Measure |
CYD Dengue Vaccine Group
n=898 participants at risk
Participants received the CYD dengue vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.
|
Placebo Group
n=300 participants at risk
All participants received a placebo at first vaccination (Month 0). Participants \<12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants \>=12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.7%
42/898 • Number of events 48 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
5.0%
15/300 • Number of events 17 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.7%
42/898 • Number of events 47 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
5.0%
15/300 • Number of events 15 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Nervous system disorders
Headache; Post-Any Injection
|
45.1%
402/891 • Number of events 402 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
38.4%
114/297 • Number of events 114 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
General disorders
Injection site Pain; Post-Any Injection
|
53.9%
481/892 • Number of events 481 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
66.7%
198/297 • Number of events 198 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
General disorders
Injection site Erythema; Post-Any Injection
|
7.2%
64/891 • Number of events 64 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
15.2%
45/297 • Number of events 45 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
General disorders
Injection site Swelling; Post-Any Injection
|
4.1%
37/892 • Number of events 37 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
8.4%
25/297 • Number of events 25 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
General disorders
Fever; Post-Any Injection
|
11.3%
101/892 • Number of events 101 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
7.4%
22/297 • Number of events 22 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
General disorders
Malaise; Post-Any Injection
|
41.8%
372/891 • Number of events 372 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
35.4%
105/297 • Number of events 105 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
General disorders
Asthenia; Post-Any Injection
|
20.5%
183/891 • Number of events 183 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
17.5%
52/297 • Number of events 52 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia; Post-Any Injection
|
44.2%
394/891 • Number of events 394 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
43.8%
130/297 • Number of events 130 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
72/898 • Number of events 77 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
9.0%
27/300 • Number of events 30 • Adverse events (AE) were collected from Day 0 (post-vaccination) up to the end of 4th year of follow up (up to 60 months).
Solicited reaction (SR) was an adverse reaction observed and reported under conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). An unsolicited AE was an observed AE that did not fulfill conditions prelisted in eCRF in terms of symptom and/or onset post-vaccination. Safety analysis set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER