An observational study in Dengue Fever, sponsored by Takeda. Recruiting at 7 sites in 3 countries. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Takeda · Observational
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).
283 studies on the registry are indexed under Dengue; 44 are open to participants now.
This study's planned enrollment of 70,000 is above the median of 595 across 80 observational studies indexed under Dengue.
Browse Dengue studies →Takeda is the lead sponsor of 1,026 studies on the registry; 89 are open to participants now.
Of its 178 completed or terminated interventional studies of FDA-regulated products, 154 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pediatric and/or adolescent residents in the study area who are age-eligible for vaccination with TDV as part of a pilot public vaccination program (children 7-10 years in Thailand, 6-10 years in Indonesia, and 7-12 years in Malaysia).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Cohort:
To be eligible for inclusion in the study cohort, participants must meet the following inclusion criteria:
Cases:
To be eligible for inclusion as a case, participants must meet the following inclusion criteria:
Controls:
To be eligible for inclusion as a matched control, participants must meet the following inclusion criteria:
Exclusion Criteria
Cases:
To be eligible for inclusion as a case participants must not meet any of the following criteria:
Controls:
To be eligible for inclusion as a control participants must not meet any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The cohort will include case and control participants. Case participants who are hospitalized and meet the study inclusion and exclusion criteria for cases, have CDD, and have a confirmed positive RT-PCR test result (VCD) will be ascertained by active hospital surveillance. Control participants who are matched to a case and meet the study inclusion and exclusion criteria for controls but have not been hospitalized with VCD on or before their case's index date (first date of hospitalization for CDD for potential cases) will be interviewed.
Other: No Intervention
This is a non-interventional study.
Hospitalization Due to VCD of Any Dengue Serotype in Unvaccinated and Fully Vaccinated Participants
Number of participants hospitalized due to VCD of any dengue serotype in unvaccinated and fully vaccinated participants.
Time frame: Up to Month 36
Hospitalization Due to VCD By Each Infecting Dengue Serotype (DENV-1, DENV-2, DENV-3, DENV-4) in Unvaccinated and Fully Vaccinated Participants
Number of participants hospitalized due to VCD with each infecting dengue serotype (dengue virus \[DENV\]-1, DENV-2, DENV-3, and DENV-4) in unvaccinated and fully vaccinated participants will be reported.
Time frame: Up to Month 36
Hospitalization Due to VCD by Baseline Dengue Serostatus (Seronegative and Seropositive) of Any Dengue Serotype in Unvaccinated and Fully Vaccinated Participants
Number of participants hospitalized due to VCD with dengue serostatus (seronegative and seropositive) of any dengue serotype in unvaccinated and fully vaccinated participants will be reported.
Time frame: Up to Month 36
Hospitalization Due to VCD By Each Infecting Dengue Serotype and Baseline Dengue Serostatus in Unvaccinated and Fully Vaccinated Participants
Number of participants hospitalized due to VCD by each infecting dengue serotype and baseline dengue serostatus (DENV-1 in baseline seronegative, DENV-2 in baseline seronegative, DENV-3 in baseline seronegative, DENV-4 in baseline seronegative, DENV-1 in baseline seropositive, DENV-2 in baseline seropositive, DENV-3 in baseline seropositive, and DENV-4 in baseline seropositive) in unvaccinated and fully vaccinated participants will be reported.
Time frame: Up to Month 36
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Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Data sharing details ↗ · vivli.org
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