Actively Recruiting
The Association Between Prior Exposure to Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) and Dengue Hospitalization in Children and Adolescents in Southeast Asia
Led by Takeda · Updated on 2026-04-16
70000
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effectiveness of a tetravalent dengue vaccine (TDV) in reducing hospital stays due to dengue in children and adolescents aged 6 to 12 years living in Southeast Asian countries with high dengue transmission, including Thailand, Indonesia, and Malaysia. This observational study focuses on participants in a community-based cohort who may or may not receive the vaccine as part of a pilot public vaccination program where TDV is already approved. The study particularly aims to assess the vaccine's effectiveness against less common dengue virus types DENV-3 and DENV-4. The study includes a nested case-control design with two groups: cases who are hospitalized children or adolescents with confirmed dengue infection, and matched controls who live in the same neighborhood but have not been hospitalized with dengue. Participants are followed individually for up to 3 years within the cohort. The study is non-interventional, observing outcomes based on vaccination status within the existing vaccination program. Participants will be monitored through active hospital surveillance to identify dengue hospitalizations confirmed by laboratory testing. Data collected includes blood samples for RT-PCR testing, clinical diagnosis, and hospitalization records. Researchers will measure the rate of hospitalization due to dengue virus infections by serotype and baseline dengue immune status. The primary outcome is dengue-related hospitalization up to 36 months. Parents or legal representatives provide consent and assent for participants, including agreement for blood sample collection and follow-up over the study period.
CONDITIONS
Brief 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...
- Participant is a child or adolescent aged 6 to 12 years eligible for TDV vaccination in the study area
- Participant's family does not plan to move away from the hospital catchment area within 3 years
- Parent or legal representative signs informed consent before any study procedures
- Participant provides age-appropriate assent before study procedures
- Parent or legal representative agrees to baseline blood sample collection
- Case participants must be hospitalized with clinical dengue diagnosis and positive RT-PCR test
- Control participants must be part of the cohort, live in the same neighborhood as their matched case, not hospitalized with dengue before the case's hospitalization date, and have a birth year matching the case
You will not qualify if you...
- Participants vaccinated with TDV, CYD-TDV, or investigational dengue vaccines before cohort enrollment
- Participants with contraindications according to local vaccine label or product information
- Control participants who could not be contacted when selected as controls
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants are observed to identify hospitalization due to dengue virus infection and to assess prior vaccination status.
Ongoing monitoring through hospital surveillance and interviews as applicable
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
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here