Trial Outcomes & Findings for Study of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia (NCT NCT01254422)
NCT ID: NCT01254422
Last Updated: 2022-03-25
Results Overview
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited injection site reactions: Pain: Incapacitating, unable to perform usual activities; Erythema and Swelling: \>=50 millimeter (mm). Grade 3 Solicited systemic reactions: Fever: \>=39°Degree Celsius (C); Headache, Malaise, Myalgia, and Asthenia: Significant: Prevents daily activity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
250 participants
Primary outcome timeframe
Day 0 up to Day 14 post-any and each vaccination
Results posted on
2022-03-25
Participant Flow
Study participants were enrolled from 02 December 2010 to 10 February 2011 at 4 clinical sites in Malaysia.
A total of 250 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 3 injections (Inj.) of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Placebo Group
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
199
|
51
|
|
Overall Study
COMPLETED
|
196
|
50
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
CYD Dengue Vaccine Group
Participants received 3 injections (Inj.) of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Placebo Group
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Serious adverse event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Study of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia
Baseline characteristics by cohort
| Measure |
CYD Dengue Vaccine Group
n=199 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Placebo Group
n=51 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
2 to 5 years
|
99 Years
n=5 Participants
|
26 Years
n=7 Participants
|
125 Years
n=5 Participants
|
|
Age, Customized
6 to 11 years
|
100 Years
n=5 Participants
|
25 Years
n=7 Participants
|
125 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
96 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to Day 14 post-any and each vaccinationPopulation: Analysis was performed on safety analysis set which included participants who received any dose of CYD dengue vaccine or placebo and were analyzed according to the treatment received at this injection. 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: Pain: Incapacitating, unable to perform usual activities; Erythema and Swelling: \>=50 millimeter (mm). Grade 3 Solicited systemic reactions: Fever: \>=39°Degree Celsius (C); Headache, Malaise, Myalgia, and Asthenia: Significant: Prevents daily activity.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=199 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Placebo Group
n=51 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj. site Swelling; Post-Inj. 2
|
15.2 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Inj. site Swelling; Post-Inj. 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj. site Pain; Post-Inj. 3
|
40.0 Percentage of participants
|
38.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj. site Erythema; Post-Inj. 3
|
23.6 Percentage of participants
|
24.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Inj. site Erythema; Post-Inj. 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj. site Swelling; Post-Inj. 3
|
20.0 Percentage of participants
|
24.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Inj. site Swelling; Post-Inj. 3
|
0.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Asthenia; Post-Any Inj.
|
47.2 Percentage of participants
|
33.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Asthenia; Post-Any Inj.
|
3.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Fever; Post-Inj. 1
|
12.6 Percentage of participants
|
8.2 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Fever; Post-Inj. 1
|
2.0 Percentage of participants
|
4.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Myalgia; Post-Inj. 3
|
17.4 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj. site Swelling; Post-Any Inj.
|
38.7 Percentage of participants
|
35.3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Inj. site Swelling; Post-Any Inj.
|
0.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj. site Pain; Post-Inj. 1
|
41.4 Percentage of participants
|
27.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Inj. site Pain; Post-Inj. 1
|
0.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj. site Erythema; Post-Inj. 1
|
22.2 Percentage of participants
|
23.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj. site Pain; Post-Any Inj.
|
69.3 Percentage of participants
|
56.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Inj. site Pain; Post-Any Inj.
|
1.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj. site Erythema; Post-Any Inj.
|
46.7 Percentage of participants
|
49.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Inj. site Erythema; Post-Any Inj.
|
0.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Myalgia; Post-Any Inj.
|
37.7 Percentage of participants
|
31.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Myalgia; Post-Any Inj.
|
2.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Inj. site Erythema; Post-Inj. 1
|
0.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj. site Swelling; Post-Inj. 1
|
18.7 Percentage of participants
|
21.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Inj. site Swelling; Post-Inj. 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj. site Pain; Post-Inj. 2
|
48.2 Percentage of participants
|
26.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Inj. site Pain; Post-Inj. 2
|
0.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Inj. site Erythema; Post-Inj. 2
|
33.0 Percentage of participants
|
32.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Inj. site Erythema; Post-Inj. 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Asthenia; Post-Inj. 1
|
28.1 Percentage of participants
|
19.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Asthenia; Post-Inj. 1
|
2.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Headache; Post-Inj. 1
|
37.2 Percentage of participants
|
27.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Headache; Post-Inj. 1
|
1.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Malaise; Post-Inj. 1
|
36.4 Percentage of participants
|
29.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Malaise; Post-Inj. 1
|
2.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Myalgia; Post-Inj. 1
|
22.7 Percentage of participants
|
23.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Myalgia; Post-Inj. 1
|
2.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Asthenia; Post-Inj. 2
|
23.9 Percentage of participants
|
6.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Asthenia; Post-Inj. 2
|
0.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Fever; Post-Inj. 2
|
15.2 Percentage of participants
|
10.2 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Fever; Post-Inj. 2
|
2.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Headache; Post-Inj. 2
|
31.0 Percentage of participants
|
16.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Headache; Post-Inj. 2
|
0.5 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Malaise; Post-Inj. 2
|
27.9 Percentage of participants
|
6.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Malaise; Post-Inj. 2
|
0.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Myalgia; Post-Inj. 2
|
18.8 Percentage of participants
|
8.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Myalgia; Post-Inj. 2
|
0.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Asthenia; Post-Inj. 3
|
19.0 Percentage of participants
|
12.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Asthenia; Post-Inj. 3
|
1.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Fever; Post-Inj. 3
|
9.5 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Fever; Post-Inj. 3
|
3.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Headache; Post-Inj. 3
|
22.6 Percentage of participants
|
14.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Headache; Post-Inj. 3
|
1.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Malaise; Post-Inj. 3
|
20.5 Percentage of participants
|
12.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Malaise; Post-Inj. 3
|
1.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Myalgia; Post-Inj. 3
|
1.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Fever; Post-Any Inj.
|
29.3 Percentage of participants
|
19.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Fever; Post-Any Inj.
|
6.6 Percentage of participants
|
3.9 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Headache; Post-Any Inj.
|
52.3 Percentage of participants
|
39.2 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Headache; Post-Any Inj.
|
2.0 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Malaise; Post-Any Inj.
|
54.3 Percentage of participants
|
41.2 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Malaise; Post-Any Inj.
|
3.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Grade 3 Inj. site Pain; Post-Inj. 3
|
0.5 Percentage of participants
|
0.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 0 up to Day 14 post-each vaccinationPopulation: Analysis was performed on safety analysis set. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and '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. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype with parental dengue virus strains (serotype 1, 2, 3, and 4) in the baseline sample.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=111 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Placebo Group
n=31 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Malaise; Post-Injection 2
|
29.1 Percentage of participants
|
3.2 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Injection site Erythema; Post-Injection 3
|
21.3 Percentage of participants
|
22.6 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Fever; Post-Injection 3
|
10.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Malaise; Post-Injection 3
|
18.5 Percentage of participants
|
16.1 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Headache; Post-Injection 3
|
19.4 Percentage of participants
|
19.4 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Injection site Pain; Post-Injection 1
|
44.5 Percentage of participants
|
29.0 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Injection site Erythema; Post-Injection 1
|
14.5 Percentage of participants
|
29.0 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Injection site Swelling; Post-Injection 1
|
13.6 Percentage of participants
|
22.6 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Asthenia; Post-Injection 1
|
27.9 Percentage of participants
|
25.8 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Fever; Post-Injection 1
|
12.7 Percentage of participants
|
13.3 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Malaise; Post-Injection 1
|
38.2 Percentage of participants
|
38.7 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Myalgia; Post-Injection 1
|
22.7 Percentage of participants
|
25.8 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Headache; Post-Injection 1
|
36.9 Percentage of participants
|
29.0 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Injection site Pain; Post-Injection 2
|
48.2 Percentage of participants
|
32.3 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Injection site Erythema; Post-Injection 2
|
25.5 Percentage of participants
|
29.0 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Injection site Swelling; Post-Injection 2
|
9.1 Percentage of participants
|
16.1 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Asthenia; Post-Injection 2
|
21.8 Percentage of participants
|
9.7 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Fever; Post-Injection 2
|
18.2 Percentage of participants
|
9.7 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Myalgia; Post-Injection 2
|
19.1 Percentage of participants
|
12.9 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Headache; Post-Injection 2
|
31.8 Percentage of participants
|
12.9 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Injection site Pain; Post-Injection 3
|
34.3 Percentage of participants
|
41.9 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Injection site Swelling; Post-Injection 3
|
15.7 Percentage of participants
|
22.6 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Asthenia; Post-Injection 3
|
13.9 Percentage of participants
|
16.1 Percentage of participants
|
|
Percentage of Flavivirus-Immune Participants Reporting Solicited Injection Site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or Placebo Vaccine
Myalgia; Post-Injection 3
|
14.8 Percentage of participants
|
16.1 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 0 up to Day 14 post-each vaccinationPopulation: Analysis was performed on safety analysis set. Here, ''overall number of participants analyzed" signifies participants evaluable for this outcome measure and '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. Flavivirus-Naive participants were defined as participants without quantified antibodies against Japanese encephalitis and without antibody quantified against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=88 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Placebo Group
n=20 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Injection site Swelling; Post-Injection 1
|
25.0 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Asthenia; Post-Injection 1
|
28.4 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Fever; Post-Injection 1
|
12.5 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Myalgia; Post-Injection 1
|
22.7 Percentage of participants
|
20.0 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Asthenia; Post-Injection 2
|
26.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Myalgia; Post-Injection 2
|
18.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Injection site Pain; Post-Injection 1
|
37.5 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Injection site Erythema; Post-Injection 1
|
31.8 Percentage of participants
|
15.0 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Malaise; Post-Injection 1
|
34.1 Percentage of participants
|
15.0 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Headache; Post-Injection 1
|
37.5 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Injection site Pain; Post-Injection 2
|
48.3 Percentage of participants
|
15.8 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Injection site Erythema; Post-Injection 2
|
42.5 Percentage of participants
|
36.8 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Injection site Swelling; Post-Injection 2
|
23.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Fever; Post-Injection 2
|
11.5 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Malaise; Post-Injection 2
|
26.4 Percentage of participants
|
10.5 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Headache; Post-Injection 2
|
29.9 Percentage of participants
|
21.1 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Injection site Pain; Post-Injection 3
|
47.1 Percentage of participants
|
31.6 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Injection site Erythema; Post-Injection 3
|
26.4 Percentage of participants
|
26.3 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Injection site Swelling; Post-Injection 3
|
25.3 Percentage of participants
|
26.3 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Asthenia; Post-Injection 3
|
25.3 Percentage of participants
|
5.3 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Fever; Post-Injection 3
|
8.2 Percentage of participants
|
5.3 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Malaise; Post-Injection 3
|
23.0 Percentage of participants
|
5.3 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Myalgia; Post-Injection 3
|
20.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Flavivirus-Naïve Participants Reporting Solicited Injection-site and Systemic Reactions Following Each Vaccination With CYD Dengue Vaccine or a Placebo Vaccine
Headache; Post-Injection 3
|
26.4 Percentage of participants
|
5.3 Percentage of participants
|
PRIMARY outcome
Timeframe: Pre-Injection 1 and Post-Injections 2 and 3Population: Analysis was performed on Full analysis set which included participants who received at least one injection of CYD dengue vaccine or placebo and had at least one valid post-injection serology result. Here, 'number analyzed' = participants with available data for each specified category.
Seropositivity was defined as participants achieving neutralizing antibody titers \>=10 (1/dilution) against each dengue serotype (1,2, 3 and 4) and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=196 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Placebo Group
n=50 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 1
|
27.6 Percentage of participants
|
30.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 1
|
31.1 Percentage of participants
|
32.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 2
|
90.3 Percentage of participants
|
34.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 3
|
96.4 Percentage of participants
|
30.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 2
|
94.9 Percentage of participants
|
34.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 3
|
96.9 Percentage of participants
|
34.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 1
|
36.7 Percentage of participants
|
36.7 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 2
|
98.5 Percentage of participants
|
32.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 3
|
99.0 Percentage of participants
|
34.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 1
|
24.0 Percentage of participants
|
30.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 2
|
91.8 Percentage of participants
|
32.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 3
|
98.0 Percentage of participants
|
28.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Pre-Injection 1 and Post-Injections 2 and 3Population: Analysis was performed on Full analysis set.
Seropositivity was defined as participants achieving neutralizing antibody titers \>=10 (1/dilution) against each dengue serotype (1, 2, 3, and 4) and was assessed using the dengue PRNT.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=196 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Placebo Group
n=50 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Pre-Injection 1
|
44.9 Percentage of participants
|
48.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Post-Injection 2
|
100.0 Percentage of participants
|
46.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 1 serotype; Post-Injection 3
|
100.0 Percentage of participants
|
42.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Pre-Injection 1
|
29.1 Percentage of participants
|
28.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Post-Injection 2
|
99.0 Percentage of participants
|
34.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 2 serotypes; Post-Injection 3
|
100.0 Percentage of participants
|
32.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Pre-Injection 1
|
25.5 Percentage of participants
|
28.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Post-Injection 2
|
96.4 Percentage of participants
|
28.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
At least 3 serotypes; Post-Injection 3
|
98.5 Percentage of participants
|
30.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Pre-Injection 1
|
19.9 Percentage of participants
|
24.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Post-Injection 2
|
80.1 Percentage of participants
|
24.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against at Least One, Two, Three, or the Four Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
All 4 serotypes; Post-Injection 3
|
91.8 Percentage of participants
|
22.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Pre-Injection 1 and Post-Injections 2 and 3Population: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for each specified category.
GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the dengue PRNT.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=196 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Placebo Group
n=50 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 1
|
15.9 Titers (1/dilution)
Interval 11.8 to 21.3
|
18.6 Titers (1/dilution)
Interval 10.0 to 34.5
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 1
|
15.6 Titers (1/dilution)
Interval 12.3 to 19.9
|
15.9 Titers (1/dilution)
Interval 9.57 to 26.5
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 3
|
193 Titers (1/dilution)
Interval 161.0 to 231.0
|
16.3 Titers (1/dilution)
Interval 9.81 to 27.0
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 1
|
9.92 Titers (1/dilution)
Interval 8.17 to 12.0
|
12.3 Titers (1/dilution)
Interval 7.96 to 19.0
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 2
|
110 Titers (1/dilution)
Interval 88.9 to 136.0
|
13.3 Titers (1/dilution)
Interval 7.94 to 22.1
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 3
|
114 Titers (1/dilution)
Interval 97.0 to 134.0
|
10.9 Titers (1/dilution)
Interval 7.34 to 16.2
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 1
|
15.3 Titers (1/dilution)
Interval 11.5 to 20.4
|
18.6 Titers (1/dilution)
Interval 9.69 to 35.8
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 2
|
119 Titers (1/dilution)
Interval 90.7 to 155.0
|
21.0 Titers (1/dilution)
Interval 10.6 to 41.9
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 3
|
151 Titers (1/dilution)
Interval 121.0 to 188.0
|
18.9 Titers (1/dilution)
Interval 9.94 to 35.8
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 2
|
160 Titers (1/dilution)
Interval 127.0 to 203.0
|
17.9 Titers (1/dilution)
Interval 9.91 to 32.2
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 3
|
180 Titers (1/dilution)
Interval 146.0 to 221.0
|
16.3 Titers (1/dilution)
Interval 9.59 to 27.7
|
|
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 2
|
196 Titers (1/dilution)
Interval 163.0 to 235.0
|
15.9 Titers (1/dilution)
Interval 9.27 to 27.4
|
PRIMARY outcome
Timeframe: Pre-Injection 1 and Post-Injections 2 and 3Population: Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Seropositivity was defined as participants achieving neutralizing antibody titers \>=10 (1/dilution) against each serotype (1, 2, 3, and 4) and was assessed using the Dengue PRNT. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=109 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Placebo Group
n=31 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants
Serotype 1; Post-Injection 2
|
96.3 Percentage of participants
|
48.4 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants
Serotype 1; Pre-Injection 1
|
56.0 Percentage of participants
|
51.6 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants
Serotype 1; Post-Injection 3
|
97.2 Percentage of participants
|
41.9 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants
Serotype 2; Pre-Injection 1
|
49.5 Percentage of participants
|
48.4 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants
Serotype 2; Post-Injection 2
|
96.3 Percentage of participants
|
54.8 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants
Serotype 2; Post-Injection 3
|
97.2 Percentage of participants
|
48.4 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants
Serotype 3; Pre-Injection 1
|
66.1 Percentage of participants
|
60.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants
Serotype 3; Post-Injection 2
|
100.0 Percentage of participants
|
51.6 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants
Serotype 3; Post-Injection 3
|
99.1 Percentage of participants
|
48.4 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants
Serotype 4; Pre-Injection 1
|
43.1 Percentage of participants
|
48.4 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants
Serotype 4; Post-Injection 2
|
97.2 Percentage of participants
|
45.2 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Immune Participants
Serotype 4; Post-Injection 3
|
100.0 Percentage of participants
|
41.9 Percentage of participants
|
PRIMARY outcome
Timeframe: Pre-Injection 1 and Post-Injections 2 and 3Population: Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Seropositivity was defined as participants achieving neutralizing antibody titers \>=10 (1/dilution) against each serotype (1, 2, 3, and 4) and was assessed using the Dengue PRNT. Flavivirus naïve participants were defined as participants without quantified antibodies against Japanese encephalitis and without quantified antibodies against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=87 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Placebo Group
n=19 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants
Serotype 4; Pre-Injection 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants
Serotype 4; Post-Injection 2
|
85.1 Percentage of participants
|
10.5 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants
Serotype 1; Pre-Injection 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants
Serotype 1; Post-Injection 2
|
82.8 Percentage of participants
|
10.5 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants
Serotype 1; Post-Injection 3
|
95.4 Percentage of participants
|
10.5 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants
Serotype 2; Pre-Injection 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants
Serotype 2; Post-Injection 2
|
93.1 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants
Serotype 2; Post-Injection 3
|
96.6 Percentage of participants
|
10.5 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants
Serotype 3; Pre-Injection 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants
Serotype 3; Post-Injection 2
|
96.6 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants
Serotype 3; Post-Injection 3
|
98.9 Percentage of participants
|
10.5 Percentage of participants
|
|
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo: Flavivirus-Naive Participants
Serotype 4; Post-Injection 3
|
95.4 Percentage of participants
|
5.3 Percentage of participants
|
PRIMARY outcome
Timeframe: Pre-Injection 1 and Post-Injections 2 and 3Population: Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the Dengue PRNT. Flavivirus-Immune participants were defined as participants with quantified antibodies against Japanese encephalitis and/or against at least 1 serotype (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=109 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Placebo Group
n=31 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 2
|
306 Titers (1/dilution)
Interval 221.0 to 424.0
|
39.0 Titers (1/dilution)
Interval 16.7 to 91.3
|
|
GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 2
|
296 Titers (1/dilution)
Interval 230.0 to 381.0
|
32.4 Titers (1/dilution)
Interval 14.8 to 71.0
|
|
GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 3
|
287 Titers (1/dilution)
Interval 219.0 to 376.0
|
29.5 Titers (1/dilution)
Interval 14.2 to 61.1
|
|
GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 1
|
17.1 Titers (1/dilution)
Interval 12.5 to 23.5
|
21.3 Titers (1/dilution)
Interval 11.3 to 40.1
|
|
GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 2
|
152 Titers (1/dilution)
Interval 115.0 to 201.0
|
21.7 Titers (1/dilution)
Interval 10.0 to 46.9
|
|
GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 1
|
37.5 Titers (1/dilution)
Interval 24.0 to 58.6
|
41.7 Titers (1/dilution)
Interval 16.0 to 109.0
|
|
GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 2
|
248 Titers (1/dilution)
Interval 171.0 to 361.0
|
45.4 Titers (1/dilution)
Interval 16.3 to 127.0
|
|
GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 3
|
247 Titers (1/dilution)
Interval 178.0 to 343.0
|
33.5 Titers (1/dilution)
Interval 13.3 to 84.4
|
|
GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 1
|
39.9 Titers (1/dilution)
Interval 25.2 to 63.1
|
41.6 Titers (1/dilution)
Interval 17.0 to 102.0
|
|
GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 3
|
292 Titers (1/dilution)
Interval 217.0 to 395.0
|
30.0 Titers (1/dilution)
Interval 13.8 to 64.9
|
|
GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 1
|
38.8 Titers (1/dilution)
Interval 27.3 to 55.4
|
33.2 Titers (1/dilution)
Interval 16.1 to 68.5
|
|
GMTs of Flavivirus-Immune Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 3
|
155 Titers (1/dilution)
Interval 125.0 to 191.0
|
16.5 Titers (1/dilution)
Interval 9.17 to 29.7
|
PRIMARY outcome
Timeframe: Pre-Injection 1 and Post- Injections 2 and 3Population: Analysis was performed on Full analysis set. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
GMTs of antibodies against the dengue virus serotypes (1, 2, 3, and 4) were assessed using the Dengue PRNT. Flavivirus-Naive participants were defined as participants without quantified antibodies against Japanese encephalitis and without antibody quantified against all serotypes (1, 2, 3, and 4) with parental dengue virus strains in the baseline sample.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=87 Participants
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Placebo Group
n=19 Participants
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 3
|
78.0 Titers (1/dilution)
Interval 62.0 to 98.1
|
5.54 Titers (1/dilution)
Interval 4.47 to 6.87
|
|
GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Pre-Injection 1
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Pre-Injection 1
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 2
|
116 Titers (1/dilution)
Interval 92.6 to 146.0
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 3; Post-Injection 3
|
117 Titers (1/dilution)
Interval 97.4 to 141.0
|
6.17 Titers (1/dilution)
Interval 4.52 to 8.41
|
|
GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 2
|
47.1 Titers (1/dilution)
Interval 35.3 to 62.9
|
5.98 Titers (1/dilution)
Interval 4.62 to 7.74
|
|
GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 1; Post-Injection 3
|
81.6 Titers (1/dilution)
Interval 66.3 to 101.0
|
7.38 Titers (1/dilution)
Interval 3.88 to 14.0
|
|
GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Pre-Injection 1
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 2
|
71.4 Titers (1/dilution)
Interval 55.4 to 92.1
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 2; Post-Injection 3
|
97.5 Titers (1/dilution)
Interval 77.5 to 123.0
|
6.03 Titers (1/dilution)
Interval 4.43 to 8.21
|
|
GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Pre-Injection 1
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
5.00 Titers (1/dilution)
Interval 5.0 to 5.0
|
|
GMT of Flavivirus-Naïve Participants Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Serotype 4; Post-Injection 2
|
73.3 Titers (1/dilution)
Interval 53.7 to 100.0
|
5.95 Titers (1/dilution)
Interval 4.47 to 7.91
|
Adverse Events
CYD Dengue Vaccine Group
Serious events: 11 serious events
Other events: 138 other events
Deaths: 0 deaths
Placebo Group
Serious events: 7 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CYD Dengue Vaccine Group
n=199 participants at risk
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Placebo Group
n=51 participants at risk
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Overdose
|
0.50%
1/199 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
0.00%
0/51 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.00%
0/199 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
2.0%
1/51 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Congenital, familial and genetic disorders
Fibrous dysplasia of bone
|
0.00%
0/199 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
2.0%
1/51 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.50%
1/199 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
3.9%
2/51 • Number of events 3 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Nervous system disorders
Febrile convulsion
|
0.50%
1/199 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
0.00%
0/51 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/199 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
2.0%
1/51 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.50%
1/199 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
0.00%
0/51 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Infections and infestations
Acute tonsillitis
|
0.50%
1/199 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
0.00%
0/51 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Infections and infestations
Enterocolitis infectious
|
0.50%
1/199 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
0.00%
0/51 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
1.0%
2/199 • Number of events 2 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
0.00%
0/51 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/199 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
2.0%
1/51 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Infections and infestations
Lobar pneumonia
|
0.50%
1/199 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
0.00%
0/51 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.50%
1/199 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
0.00%
0/51 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Infections and infestations
Pneumonia
|
0.50%
1/199 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
2.0%
1/51 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Infections and infestations
Scarlet fever
|
0.50%
1/199 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
0.00%
0/51 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Infections and infestations
Viral infection
|
0.50%
1/199 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
0.00%
0/51 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Infections and infestations
Viral pharyngitis
|
0.50%
1/199 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
2.0%
1/51 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
Other adverse events
| Measure |
CYD Dengue Vaccine Group
n=199 participants at risk
Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
|
Placebo Group
n=51 participants at risk
Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.1%
24/199 • Number of events 27 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
2.0%
1/51 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Nervous system disorders
Headache; Post-Any Injection
|
52.3%
104/199 • Number of events 104 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
39.2%
20/51 • Number of events 20 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
General disorders
Pyrexia
|
7.0%
14/199 • Number of events 14 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
2.0%
1/51 • Number of events 1 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
General disorders
Injection site Pain; Post-Any
|
69.3%
138/199 • Number of events 138 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
56.9%
29/51 • Number of events 29 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
General disorders
Injection site Erythema; Post-Any
|
46.7%
93/199 • Number of events 93 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
49.0%
25/51 • Number of events 25 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
General disorders
Injection site Swelling; Post-Any
|
38.7%
77/199 • Number of events 77 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
35.3%
18/51 • Number of events 18 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
General disorders
Asthenia; Post-Any Injection
|
47.2%
94/199 • Number of events 94 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
33.3%
17/51 • Number of events 17 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
General disorders
Fever; Post-Any Injection
|
29.3%
58/198 • Number of events 58 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
19.6%
10/51 • Number of events 10 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
General disorders
Malaise; Post-Any Injection
|
54.3%
108/199 • Number of events 108 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
41.2%
21/51 • Number of events 21 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
7/199 • Number of events 7 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
5.9%
3/51 • Number of events 3 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia; Post-Any Injection
|
37.7%
75/199 • Number of events 75 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
31.4%
16/51 • Number of events 16 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.1%
50/199 • Number of events 61 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on Safety analysis set.
|
21.6%
11/51 • Number of events 15 • Adverse events (AEs) were collected from Day 0 (post-vaccination) up to 6 months post-Injection 3 (up to 18 months)
Analysis was performed on 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