Trial Outcomes & Findings for Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study (NCT NCT01983553)
NCT ID: NCT01983553
Last Updated: 2022-03-29
Results Overview
Event rate per 100 participant-years for hospitalized VCD cases, due to any and each serotype (1, 2, 3 and 4) following vaccination with either CYD Dengue vaccine or Placebo in the previous study (CYD23) were reported.
Recruitment status
COMPLETED
Target enrollment
3203 participants
Primary outcome timeframe
Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23
Results posted on
2022-03-29
Participant Flow
Study participants were enrolled in the original study CYD23 (NCT00842530) from 10 September 2013 to 29 November 2013 at 1 clinic center in Thailand.
Of the 3997 participants who were treated in the original study CYD23, a total of 3203 participants were included in this CYD57 study to continue the 4-year safety follow-up.
Participant milestones
| Measure |
CYD Dengue Vaccine Group
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
Control Group
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
|---|---|---|
|
Overall Study
STARTED
|
2131
|
1072
|
|
Overall Study
COMPLETED
|
2131
|
1072
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study
Baseline characteristics by cohort
| Measure |
CYD Dengue Vaccine Group
n=2131 Participants
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
Control Group
n=1072 Participants
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
Total
n=3203 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2131 Participants
n=5 Participants
|
1072 Participants
n=7 Participants
|
3203 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
8.11 Years
STANDARD_DEVIATION 2.02 • n=5 Participants
|
8.15 Years
STANDARD_DEVIATION 2.06 • n=7 Participants
|
8.13 Years
STANDARD_DEVIATION 2.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1118 Participants
n=5 Participants
|
579 Participants
n=7 Participants
|
1697 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1013 Participants
n=5 Participants
|
493 Participants
n=7 Participants
|
1506 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23Population: Analysis was performed on FupAS.
Event rate per 100 participant-years for hospitalized VCD cases, due to any and each serotype (1, 2, 3 and 4) following vaccination with either CYD Dengue vaccine or Placebo in the previous study (CYD23) were reported.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=2131 Participants
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
Control Group
n=1072 Participants
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
|---|---|---|
|
Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23)
Any of the 4 Serotypes
|
1.0 Events per 100 participant-years
Interval 0.8 to 1.2
|
1.1 Events per 100 participant-years
Interval 0.8 to 1.4
|
|
Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23)
Serotype 1
|
0.2 Events per 100 participant-years
Interval 0.2 to 0.4
|
0.3 Events per 100 participant-years
Interval 0.1 to 0.5
|
|
Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23)
Serotype 2
|
0.3 Events per 100 participant-years
Interval 0.2 to 0.5
|
0.3 Events per 100 participant-years
Interval 0.1 to 0.5
|
|
Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23)
Serotype 3
|
0.2 Events per 100 participant-years
Interval 0.2 to 0.4
|
0.2 Events per 100 participant-years
Interval 0.1 to 0.4
|
|
Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23)
Serotype 4
|
0.2 Events per 100 participant-years
Interval 0.1 to 0.3
|
0.3 Events per 100 participant-years
Interval 0.1 to 0.5
|
|
Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23)
Unserotyped
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.0
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.2
|
PRIMARY outcome
Timeframe: Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23Population: Analysis was performed on FupAS.
Cases were defined as the number of participants with at least one hospitalized VCD episode.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=2131 Participants
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
Control Group
n=1072 Participants
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
|---|---|---|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23)
Cases: Any of the 4 Serotypes
|
85 Cases
|
46 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23)
Cases: Serotype 1
|
21 Cases
|
11 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23)
Cases: Serotype 2
|
29 Cases
|
11 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23)
Cases: Serotype 3
|
21 Cases
|
10 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23)
Cases: Serotype 4
|
15 Cases
|
12 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23)
Cases: Unserotyped
|
0 Cases
|
3 Cases
|
PRIMARY outcome
Timeframe: Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23Population: Analysis was performed on FupAS.
Episodes were defined as the number of hospitalized VCD episodes.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=2131 Participants
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
Control Group
n=1072 Participants
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
|---|---|---|
|
Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23)
Episodes: Any of the 4 Serotypes
|
85 Episodes
|
46 Episodes
|
|
Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23)
Episodes: Serotype 1
|
21 Episodes
|
11 Episodes
|
|
Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23)
Episodes: Serotype 2
|
29 Episodes
|
11 Episodes
|
|
Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23)
Episodes: Serotype 3
|
21 Episodes
|
10 Episodes
|
|
Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23)
Episodes: Serotype 4
|
15 Episodes
|
12 Episodes
|
|
Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23)
Episodes: Unserotyped
|
0 Episodes
|
3 Episodes
|
PRIMARY outcome
Timeframe: Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23Population: Analysis was performed on FupAS. Here, "number analyzed" signifies participants with available data for each specified category.
Event rate per 100 participant-years for hospitalized VCD cases, due to any and each serotype (1, 2, 3 and 4) following vaccination with either CYD Dengue vaccine or Placebo in the previous study (CYD23) were reported. Endpoint values \<0.1 were rounded to 0.1.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=2131 Participants
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
Control Group
n=1072 Participants
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
|---|---|---|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
6 to 11 Years: Any of the 4 Serotypes
|
0.8 Events per 100 participant-years
Interval 0.6 to 1.1
|
1.1 Events per 100 participant-years
Interval 0.7 to 1.4
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
4 to 5 Years: Serotype 1
|
0.6 Events per 100 participant-years
Interval 0.3 to 1.2
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.7
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
6 to 11 Years: Serotype 1
|
0.2 Events per 100 participant-years
Interval 0.1 to 0.3
|
0.3 Events per 100 participant-years
Interval 0.1 to 0.5
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
4 to 5 Years: Any of the 4 Serotypes
|
1.7 Events per 100 participant-years
Interval 1.1 to 2.4
|
1.2 Events per 100 participant-years
Interval 0.5 to 2.2
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
4 to 5 Years: Serotype 2
|
0.4 Events per 100 participant-years
Interval 0.1 to 0.8
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.7
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
6 to 11 Years: Serotype 2
|
0.3 Events per 100 participant-years
Interval 0.2 to 0.5
|
0.3 Events per 100 participant-years
Interval 0.1 to 0.5
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
4 to 5 Years: Serotype 3
|
0.3 Events per 100 participant-years
Interval 0.1 to 0.7
|
0.3 Events per 100 participant-years
Interval 0.0 to 0.9
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
6 to 11 Years: Serotype 3
|
0.2 Events per 100 participant-years
Interval 0.1 to 0.4
|
0.2 Events per 100 participant-years
Interval 0.1 to 0.4
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
4 to 5 Years: Serotype 4
|
0.4 Events per 100 participant-years
Interval 0.1 to 0.8
|
0.4 Events per 100 participant-years
Interval 0.1 to 1.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
6 to 11 Years: Serotype 4
|
0.1 Events per 100 participant-years
Interval 0.1 to 0.2
|
0.3 Events per 100 participant-years
Interval 0.1 to 0.5
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
4 to 5 Years: Unserotyped
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.2
|
0.3 Events per 100 participant-years
Interval 0.0 to 0.9
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
6 to 11 Years: Unserotyped
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.2
|
PRIMARY outcome
Timeframe: Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23Population: Analysis was performed on FupAS. Here, "number analyzed" signifies participants with evaluable data for each specified category.
Cases were defined as the number of participants with at least one hospitalized VCD episode.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=2131 Participants
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
Control Group
n=1072 Participants
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
|---|---|---|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
4 to 5 years cases: Any of the 4 serotype
|
26 Cases
|
9 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
6 to 11 years cases: Any of the 4 Serotypes
|
59 Cases
|
37 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
4 to 5 years cases: Serotype 1
|
10 Cases
|
1 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
6 to 11 years cases: Serotype 1
|
11 Cases
|
10 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
4 to 5 years cases: Serotype 2
|
6 Cases
|
1 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
6 to 11 years cases: Serotype 2
|
23 Cases
|
10 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
4 to 5 years cases: Serotype 3
|
5 Cases
|
2 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
6 to 11 years cases: Serotype 3
|
16 Cases
|
8 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
4 to 5 years cases: Serotype 4
|
6 Cases
|
3 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
6 to 11 years cases: Serotype 4
|
9 Cases
|
9 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
4 to 5 years cases: Unserotyped
|
0 Cases
|
2 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
6 to 11 years cases: Unserotyped
|
0 Cases
|
1 Cases
|
PRIMARY outcome
Timeframe: Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23Population: Analysis was performed on FupAS. Here, "number analyzed" signifies participants with evaluable data for each specified category.
Episodes were defined as the number of hospitalized VCD episodes.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=2131 Participants
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
Control Group
n=1072 Participants
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
|---|---|---|
|
Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
6 to 11 years episodes: Serotype 3
|
16 Episodes
|
8 Episodes
|
|
Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
4 to 5 years episodes: Any of 4 serotype
|
26 Episodes
|
9 Episodes
|
|
Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
6 to11 years episodes: Any of 4 Serotypes
|
59 Episodes
|
37 Episodes
|
|
Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
4 to 5 years episodes: Serotype 1
|
10 Episodes
|
1 Episodes
|
|
Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
6 to 11 years episodes: Serotype 1
|
11 Episodes
|
10 Episodes
|
|
Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
4 to 5 years episodes: Serotype 2
|
6 Episodes
|
1 Episodes
|
|
Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
6 to 11 years episodes: Serotype 2
|
23 Episodes
|
10 Episodes
|
|
Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
4 to 5 years episodes: Serotype 3
|
5 Episodes
|
2 Episodes
|
|
Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
4 to 5 years episodes: Serotype 4
|
6 Episodes
|
3 Episodes
|
|
Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
6 to 11 years episodes: Serotype 4
|
9 Episodes
|
9 Episodes
|
|
Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
4 to 5 years episodes: Unserotyped
|
0 Episodes
|
2 Episodes
|
|
Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
6 to 11 years episodes: Unserotyped
|
0 Episodes
|
1 Episodes
|
PRIMARY outcome
Timeframe: Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23Population: Analysis was performed on FupAS.
Event rate per 100 participant-years for Clinically Severe hospitalized VCD cases, due to any and each serotype (1, 2, 3 and 4) following vaccination with either CYD Dengue vaccine or Placebo in the previous study (CYD23) were reported. Endpoint values \<0.1 were rounded to 0.1.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=2131 Participants
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
Control Group
n=1072 Participants
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
|---|---|---|
|
Event Rate Per 100 Participant-years for Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Any of the 4 Serotypes
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.2
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.2
|
|
Event Rate Per 100 Participant-years for Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 1
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.2
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 2
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 3
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 4
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.2
|
|
Event Rate Per 100 Participant-years for Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Unserotyped
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.0
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
PRIMARY outcome
Timeframe: Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23Population: Analysis was performed on FupAS.
Cases were defined as the number of participants with at least one hospitalized VCD episode.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=2131 Participants
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
Control Group
n=1072 Participants
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
|---|---|---|
|
Number of Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Any of the 4 Serotypes
|
8 Cases
|
3 Cases
|
|
Number of Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 1
|
6 Cases
|
0 Cases
|
|
Number of Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 2
|
1 Cases
|
1 Cases
|
|
Number of Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 3
|
1 Cases
|
0 Cases
|
|
Number of Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 4
|
1 Cases
|
2 Cases
|
|
Number of Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Unserotyped
|
0 Cases
|
0 Cases
|
PRIMARY outcome
Timeframe: Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23Population: Analysis was performed on FupAS.
Episodes were defined as the number of hospitalized VCD episodes.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=2131 Participants
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
Control Group
n=1072 Participants
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
|---|---|---|
|
Number of Episodes of Clinically Severe Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 4
|
1 Episodes
|
2 Episodes
|
|
Number of Episodes of Clinically Severe Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Any of the 4 Serotypes
|
8 Episodes
|
3 Episodes
|
|
Number of Episodes of Clinically Severe Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 1
|
6 Episodes
|
0 Episodes
|
|
Number of Episodes of Clinically Severe Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 2
|
1 Episodes
|
1 Episodes
|
|
Number of Episodes of Clinically Severe Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 3
|
1 Episodes
|
0 Episodes
|
|
Number of Episodes of Clinically Severe Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Unserotyped
|
0 Episodes
|
0 Episodes
|
PRIMARY outcome
Timeframe: During Year 1 to Year 4 post 3rd vaccination at Month 12 in CYD23 at each of the following time points: Anytime, 0-3 days, 4-7 days, 0-7 days, After 7 days during the sera sample collection time interval of 14 daysPopulation: Analysis was performed on FupAS. Here, 'number analyzed' = number of hospitalized VCD episodes in the specified time period.
Cases were defined as the number of participants with at least one non-serotype specific dengue viremia among hospitalized VCD cases.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=2131 Participants
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
Control Group
n=1072 Participants
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
|---|---|---|
|
Number of Cases of Non-Serotype Specific Dengue Viremia Among Hospitalized VCD Cases Following Vaccination With CYD Dengue Vaccine or Placebo in Previous Study (CYD23)
Cases - Anytime
|
78 Participants
|
42 Participants
|
|
Number of Cases of Non-Serotype Specific Dengue Viremia Among Hospitalized VCD Cases Following Vaccination With CYD Dengue Vaccine or Placebo in Previous Study (CYD23)
Cases - 0-3 days
|
25 Participants
|
12 Participants
|
|
Number of Cases of Non-Serotype Specific Dengue Viremia Among Hospitalized VCD Cases Following Vaccination With CYD Dengue Vaccine or Placebo in Previous Study (CYD23)
Cases - 4-7 days
|
53 Participants
|
27 Participants
|
|
Number of Cases of Non-Serotype Specific Dengue Viremia Among Hospitalized VCD Cases Following Vaccination With CYD Dengue Vaccine or Placebo in Previous Study (CYD23)
Cases - 0-7 days
|
78 Participants
|
39 Participants
|
|
Number of Cases of Non-Serotype Specific Dengue Viremia Among Hospitalized VCD Cases Following Vaccination With CYD Dengue Vaccine or Placebo in Previous Study (CYD23)
Cases - After 7 days
|
NA Participants
No hospitalized VCD case occurred in this specified time period.
|
3 Participants
|
PRIMARY outcome
Timeframe: Year 1 to Year 4 post-vaccination after 3rd vaccination at Month 12 in CYD23 at each of the following time points: Anytime, 0-3 days, 4-7 days, 0-7 days, After 7 days during the sample collection time interval of 14 daysPopulation: Analysis was performed on FupAS. Here, 'number analyzed' = number of hospitalized VCD episodes in the specified time period.
Quantified viremia was defined as greater than or equal to (\>=) lower limit of quantitation (log10 plaque forming unit \[pfu\]/mL).
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=2131 Participants
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
Control Group
n=1072 Participants
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
|---|---|---|
|
Non-Serotype Specific Dengue Viremia Among Hospitalized VCD Cases Following Vaccination With CYD Dengue Vaccine or Placebo in Previous Study (CYD23)
Mean Viremia - 0-3 days
|
4.35 log10 pfu/mL
Standard Deviation 1.11
|
3.83 log10 pfu/mL
Standard Deviation 1.53
|
|
Non-Serotype Specific Dengue Viremia Among Hospitalized VCD Cases Following Vaccination With CYD Dengue Vaccine or Placebo in Previous Study (CYD23)
Mean Viremia - Anytime
|
3.64 log10 pfu/mL
Standard Deviation 1.17
|
3.38 log10 pfu/mL
Standard Deviation 1.21
|
|
Non-Serotype Specific Dengue Viremia Among Hospitalized VCD Cases Following Vaccination With CYD Dengue Vaccine or Placebo in Previous Study (CYD23)
Mean Viremia - 4-7 days
|
3.31 log10 pfu/mL
Standard Deviation 1.06
|
3.12 log10 pfu/mL
Standard Deviation 0.957
|
|
Non-Serotype Specific Dengue Viremia Among Hospitalized VCD Cases Following Vaccination With CYD Dengue Vaccine or Placebo in Previous Study (CYD23)
Mean Viremia - 0-7 days
|
3.64 log10 pfu/mL
Standard Deviation 1.17
|
3.34 log10 pfu/mL
Standard Deviation 1.19
|
|
Non-Serotype Specific Dengue Viremia Among Hospitalized VCD Cases Following Vaccination With CYD Dengue Vaccine or Placebo in Previous Study (CYD23)
Mean Viremia - After 7 days
|
NA log10 pfu/mL
Standard Deviation NA
No hospitalized VCD case occurred in this specified time period.
|
3.88 log10 pfu/mL
Standard Deviation 1.63
|
PRIMARY outcome
Timeframe: Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23Population: Analysis was performed on FupAS.
Event rate per 100 participant-years for hospitalized VCD cases, due to any and each serotype (1, 2, 3 and 4) following vaccination with either CYD Dengue vaccine or Placebo in the previous study (CYD23) were reported. Endpoint values \<0.1 were rounded to 0.1. The WHO criteria were fever, any haemorrhagic manifestations, thrombocytopenia, plasma leakage or pleural effusion and/or ascites and/or hypoalbuminemia. Dengue haemorrhagic fever was graded as Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test. Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhages. Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness. Grade IV: Profound shock with undetectable blood pressure and pulse.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=2131 Participants
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
Control Group
n=1072 Participants
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
|---|---|---|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Any of the 4 Serotypes: Any Grade
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.2
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.2
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Any of the 4 Serotypes: Grade I
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.2
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Any of the 4 Serotypes: Grade II
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Any of the 4 Serotypes: Grade III
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Any of the 4 Serotypes: Grade IV
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.0
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 1: Any Grade
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 1: Grade I
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 1: Grade II
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 1: Grade III
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 1: Grade IV
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.0
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 2: Any Grade
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 2: Grade I
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 2: Grade II
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.0
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 2: Grade III
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.0
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 2: Grade IV
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.0
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 3: Any Grade
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 3: Grade I
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.0
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 3: Grade II
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 3 Grade III
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.0
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 3: Grade IV
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.0
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 4: Any Grade
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.2
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 4: Grade I
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.0
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 4: Grade II
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
0.1 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 4: Grade III
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.0
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Serotype 4: Grade IV
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.0
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Unserotyped: Any Grade
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.0
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Unserotyped: Grade I
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.0
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Unserotyped: Grade II
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.0
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Unserotyped: Grade III
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.0
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
|
Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Unserotyped: Grade IV
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.0
|
0.0 Events per 100 participant-years
Interval 0.0 to 0.1
|
PRIMARY outcome
Timeframe: Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23Population: Analysis was performed on FupAS.
Cases were defined as the number of participants with at least one hospitalized VCD episode meeting WHO criteria. The WHO criteria was fever, any haemorrhagic manifestations, thrombocytopenia, plasma leakage or pleural effusion and/or ascites and/or hypoalbuminemia. Dengue hemorrhagic fever was graded as - Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation was a positive tourniquet test. Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhages. Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness. Grade IV: Profound shock with undetectable blood pressure and pulse.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=2131 Participants
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
Control Group
n=1072 Participants
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
|---|---|---|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 1: Grade III
|
2 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 1: Grade IV
|
0 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 2: Any Grade
|
1 Cases
|
1 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 2: Grade I
|
1 Cases
|
1 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 2: Grade II
|
0 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 2: Grade III
|
0 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 2: Grade IV
|
0 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 3: Any Grade
|
1 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 3: Grade I
|
0 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 3: Grade II
|
1 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 3: Grade III
|
0 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 3: Grade IV
|
0 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 4: Any Grade
|
1 Cases
|
2 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 4: Grade I
|
0 Cases
|
1 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 4: Grade II
|
1 Cases
|
1 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 4: Grade III
|
0 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 4: Grade IV
|
0 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Unserotyped: Any Grade
|
0 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Unserotyped: Grade I
|
0 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Unserotyped: Grade II
|
0 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Unserotyped: Grade III
|
0 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Unserotyped: Grade IV
|
0 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Any of the 4 Serotypes: Any Grade
|
7 Cases
|
3 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Any of the 4 Serotypes: Grade I
|
1 Cases
|
2 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Any of the 4 Serotypes: Grade II
|
4 Cases
|
1 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Any of the 4 Serotypes: Grade III
|
2 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Any of the 4 Serotypes: Grade IV
|
0 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 1: Any Grade
|
5 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 1: Grade I
|
1 Cases
|
0 Cases
|
|
Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Cases: Serotype 1: Grade II
|
2 Cases
|
0 Cases
|
PRIMARY outcome
Timeframe: Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23Population: Analysis was performed on FupAS.
Episodes were defined as the number of hospitalized virologically confirmed dengue episodes meeting WHO criteria. The WHO criteria was fever, any haemorrhagic manifestations, thrombocytopenia, plasma leakage or pleural effusion and/or ascites and/or hypoalbuminemia. Dengue haemorrhagic fever was graded as Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test. Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhages. Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness. Grade IV: Profound shock with undetectable blood pressure and pulse.
Outcome measures
| Measure |
CYD Dengue Vaccine Group
n=2131 Participants
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
Control Group
n=1072 Participants
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
|---|---|---|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Any of the 4 Serotypes: Any Grade
|
7 Episodes
|
3 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Any of the 4 Serotypes: Grade I
|
1 Episodes
|
2 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Any of the 4 Serotypes: Grade II
|
4 Episodes
|
1 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Any of the 4 Serotypes: Grade III
|
2 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Any of the 4 Serotypes: Grade IV
|
0 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 1: Any Grade
|
5 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 1: Grade I
|
1 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 1: Grade II
|
2 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 1: Grade III
|
2 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 1: Grade IV
|
0 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 2: Any Grade
|
1 Episodes
|
1 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 2: Grade I
|
1 Episodes
|
1 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 2: Grade II
|
0 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 2: Grade III
|
0 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 2 Grade IV
|
0 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 3: Any Grade
|
1 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 3: Grade I
|
0 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 3: Grade II
|
1 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 3: Grade III
|
0 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 3: Grade IV
|
0 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 4: Any Grade
|
1 Episodes
|
2 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 4: Grade I
|
0 Episodes
|
1 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 4: Grade II
|
1 Episodes
|
1 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype 4: Grade III
|
0 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Serotype: 4 Grade IV
|
0 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Unserotyped: Any Grade
|
0 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Unserotyped: Grade I
|
0 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Unserotyped: Grade II
|
0 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Unserotyped: Grade III
|
0 Episodes
|
0 Episodes
|
|
Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)
Episodes: Unserotyped: Grade IV
|
0 Episodes
|
0 Episodes
|
Adverse Events
CYD Dengue Vaccine Group
Serious events: 3 serious events
Other events: 0 other events
Deaths: 3 deaths
Control Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
CYD Dengue Vaccine Group
n=2131 participants at risk
Participants who received 3 injections of 0.5 mL CYD dengue vaccine, 1 injection each at 0, 6, and 12 months, subcutaneously in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
Control Group
n=1072 participants at risk
Participants who received either 0.5 mL Rabies vaccine (Verorab®) or placebo control, subcutaneously as a first injection on Day 0, placebo for second and third injections at 6 and 12 months, respectively, in the previous study CYD23, were followed up for safety in this study for 4 years after the 3rd vaccination at Month 12 in CYD23.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Gun-shot wound
|
0.09%
2/2131 • Number of events 2 • Adverse event data was collected throughout the study period (Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23)
This study involved a passive surveillance of hospitalized dengue cases and related and fatal serious adverse events in participants that participated in a previous study (CYD23). Non-serious adverse event data was not collected since no vaccine was administered in the present study. Analysis was performed on FupAS.
|
0.00%
0/1072 • Adverse event data was collected throughout the study period (Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23)
This study involved a passive surveillance of hospitalized dengue cases and related and fatal serious adverse events in participants that participated in a previous study (CYD23). Non-serious adverse event data was not collected since no vaccine was administered in the present study. Analysis was performed on FupAS.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.05%
1/2131 • Number of events 1 • Adverse event data was collected throughout the study period (Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23)
This study involved a passive surveillance of hospitalized dengue cases and related and fatal serious adverse events in participants that participated in a previous study (CYD23). Non-serious adverse event data was not collected since no vaccine was administered in the present study. Analysis was performed on FupAS.
|
0.09%
1/1072 • Number of events 1 • Adverse event data was collected throughout the study period (Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23)
This study involved a passive surveillance of hospitalized dengue cases and related and fatal serious adverse events in participants that participated in a previous study (CYD23). Non-serious adverse event data was not collected since no vaccine was administered in the present study. Analysis was performed on FupAS.
|
|
General disorders
Drowning
|
0.00%
0/2131 • Adverse event data was collected throughout the study period (Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23)
This study involved a passive surveillance of hospitalized dengue cases and related and fatal serious adverse events in participants that participated in a previous study (CYD23). Non-serious adverse event data was not collected since no vaccine was administered in the present study. Analysis was performed on FupAS.
|
0.09%
1/1072 • Number of events 1 • Adverse event data was collected throughout the study period (Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23)
This study involved a passive surveillance of hospitalized dengue cases and related and fatal serious adverse events in participants that participated in a previous study (CYD23). Non-serious adverse event data was not collected since no vaccine was administered in the present study. Analysis was performed on FupAS.
|
Other adverse events
Adverse event data not reported
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