A Study in Children on the Effectiveness of Takeda`s Licensed Dengue Vaccine TDV against Hospitalization due to Dengue Disease
Tahapan Penelitian : Initial
Sponsor:
Takeda Vaccines Inc
Mitra Pelaksana:
N/A
No Registry
INA-2MPND35B
Tanggal Input Registry : 31-07-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 18-08-2025 |
| Outcome Primer | Hospitalization Due to VCD of Any Dengue Serotype in Unvaccinated and Fully Vaccinated Participants |
| Outcome Skunder | Hospitalization Due to VCD By Each Infecting Dengue Serotype (DENV-1, DENV-2, DENV-3, DENV-4) in Unvaccinated and Fully Vaccinated Participants |
| Descriptive Information | |
| Judul Penelitian Popular | A Study in Children on the Effectiveness of Takeda`s Licensed Dengue Vaccine TDV against Hospitalization due to Dengue Disease |
| Judul Penelitian Ilmiah | The Association Between Prior Exposure to Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) and Dengue Hospitalization in a Pediatric and Adolescent Population: a Nested Case-Control Post-Authorization Effectiveness Study |
| Jenis Penelitian | Observational |
| Intervensi | |
| Jumlah Subyek Penelitian | 30000 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 1. The participant is a child or adolescent eligible to be vaccinated with Qdenga as part of a vaccination program planned in the study area. 2. The participant’s family do not intend to migrate away from the cohort hospital catchment area within 3 years of his/her enrollment into the study cohort. 3. The participant's parent(s) or legally acceptable representative (LAR) signs and dates a written ICF, and any required privacy authorization where applicable, prior to the initiation of any study procedures, after the nature of the study has been explained according to local regulatory requirements. 4. The participant signs and dates an age-appropriate assent form prior to the initiation of any study procedures, after the nature of the study has been explained according to local regulatory requirements. In Indonesia, participants aged ≥12 years are required to sign and date an age-appropriate assent form. 5. The participant's parent(s) or LAR agrees that a baseline blood sample may be taken from the participant.Exclusion Criteria: N/A |
| Administrative Information | |
| Nomor Persetujuan Etik | KET-457/UN2.F1/ETIK/PPM.00.02/2025 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | Not applicable |
| Other Study ID Numbers | DEN-401, NCT06843226, EUPAS1000000218 |
| Contact Person | Prof. Dr. dr. Sri Rezeki Hadinegoro, Sp.A (K) |