Actively Recruiting
A Study in Children and Teenagers to Learn if a TDV Dengue Vaccination Lowers the Chance of Hospital Stays for Dengue
Led by Takeda · Updated on 2026-04-16
70000
Participants Needed
7
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main aim of this study is to collect more information on the effectiveness of TDV when used in a pilot public vaccination program for children and adolescents participating in a community-based cohort in Southeast Asian countries with high dengue transmission, specifically Thailand, Indonesia, and Malaysia where TDV is already approved for use. The study will include cohort participants (individual follow-up of 3 years) who may or may not later be vaccinated with TDV as part of a pilot public vaccination program in the study countries. The study will investigate if cohort participants who were vaccinated with TDV have less hospital stays due to dengue than cohort participants who were not vaccinated with TDV. The study will also provide further information on the effectiveness of TDV against the least common dengue virus serotypes (DENV-3 and DENV-4).
CONDITIONS
Official Title
A Study in Children and Teenagers to Learn if a TDV Dengue Vaccination Lowers the Chance of Hospital Stays for Dengue
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The participant is a child or adolescent eligible to be vaccinated with TDV as part of a vaccination program planned in the study area.
- The participant's family do not intend to migrate away from the cohort hospital catchment area within 3 years of enrollment.
- The participant's parent(s) or legally acceptable representative signs and dates a written informed consent form before any study procedures.
- The participant signs and dates an age-appropriate assent form before any study procedures.
- The participant's parent(s) or legally acceptable representative agrees that a baseline blood sample may be taken.
- For cases: participant is part of the cohort, hospitalized and clinically diagnosed with dengue, has a blood sample taken preferably within 5 days of fever or symptom onset, and tested positive for dengue by RT-PCR.
- For controls: participant is part of the cohort, not hospitalized with virologically confirmed dengue (VCD) between enrollment and index date, resides in the same neighborhood as the matched case, and has a date of birth in the same calendar year as the matched case.
You will not qualify if you...
- For cases: participant was vaccinated with TDV, CYD-TDV, or an investigational dengue vaccine before cohort enrollment.
- For cases: participant has contraindications as per the locally approved label or product information leaflet.
- For controls: participant was vaccinated with TDV, CYD-TDV, or an investigational dengue vaccine before cohort enrollment.
- For controls: participant has contraindications as per the locally approved label or product information leaflet.
- For controls: participant could not be contacted at the time of being selected as a control.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Fakultas Kedokteran Lambung Mangkurat
Banjarmasin, South Kalimantan, Indonesia, 70122
Actively Recruiting
2
Fakultas Kedokteran Universitas Sriwijaya
Palembang, South Sumatra, Indonesia, 30662
Actively Recruiting
3
Fakultas Kedokteran Universitas Indonesia
Jakarta Pusat, Indonesia, 10430
Actively Recruiting
4
Universiti Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Not Yet Recruiting
5
Pattaya Patamakhun Hospital
Chon Buri, Thailand, 20150
Active, Not Recruiting
6
Nakhon Phanom Hospital
Nakhon Phanom, Thailand, 48000
Active, Not Recruiting
7
Phra Nakhon Si Ayutthaya Hospital
Phra Nakhon Si Ayutthaya, Thailand, 13000
Active, Not Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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