N/A
Completed N=3,203
Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study
Dengue · Dengue Fever · Dengue Hemorrhagic Fever
Source: ClinicalTrials.gov NCT01983553 ↗
Enrolled (actual)
3,203
Serious AEs
0.2%
Results posted
Jul 2019
Primary outcomePrimary: 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) — 1.0; 1.1; 0.2; 0.3 Events per 100 participant-years
Summary
The purpose of this study was to conduct a passive surveillance of hospitalized dengue cases in participants who participated in study CYD23 (NCT00842530).
The Objectives:
* To describe the incidence of virologically-confirmed hospitalized dengue cases.
* To characterize hospitalized dengue cases.
* To evaluate the occurrence of related and fatal serious adverse events (SAEs).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
1.0; 1.1; 0.2; 0.3; 0.3; 0.3 | — |
| PRIMARY 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) |
85; 46; 21; 11; 29; 11 | — |
| PRIMARY 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) |
85; 46; 21; 11; 29; 11 | — |
| PRIMARY 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) |
1.7; 1.2; 0.8; 1.1; 0.6; 0.1 | — |
| PRIMARY 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) |
26; 9; 59; 37; 10; 1 | — |
| PRIMARY 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) |
26; 9; 59; 37; 10; 1 | — |
| PRIMARY 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) |
0.1; 0.1; 0.1; 0.0; 0.1; 0.1 | — |
| PRIMARY 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) |
8; 3; 6; 0; 1; 1 | — |
| PRIMARY 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) |
8; 3; 6; 0; 1; 1 | — |
| PRIMARY 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) |
78; 42; 25; 12; 53; 27 | — |
| PRIMARY Non-Serotype Specific Dengue Viremia Among Hospitalized VCD Cases Following Vaccination With CYD Dengue Vaccine or Placebo in Previous Study (CYD23) |
3.64; 3.38; 4.35; 3.83; 3.31; 3.12 | — |
| PRIMARY 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) |
0.1; 0.1; 0.1; 0.1; 0.1; 0.1 | — |
| PRIMARY 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) |
7; 3; 1; 2; 4; 1 | — |
| PRIMARY 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) |
7; 3; 1; 2; 4; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Ongoing participation in study CYD23 at the time of enrolment.
- Assent form was signed and dated by the participant (for participants >= 7 years old), and informed consent form was signed and dated by the parent(s) or another legally accepted representative and by 2 independent witnesses.
- Participant and parent/legally accepted representative were able to attend all scheduled visits to comply with all study procedures.
Exclusion Criteria
- Planned participation in another dengue clinical trial during the present study
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
Data sourced from ClinicalTrials.gov (NCT01983553). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.