A Study in Children and Adolescents on the Effectiveness of Takeda's Licensed Dengue Vaccine TDV Against Hospitalization Due to Dengue Disease
NCT ID: NCT06843226
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
70000 participants
OBSERVATIONAL
2025-03-05
2029-12-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Nested Case-control Participants
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.
No Intervention
This is a non-interventional study.
Interventions
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No Intervention
This is a non-interventional study.
Eligibility Criteria
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Inclusion Criteria
1. The participant is a child or adolescent eligible to be vaccinated with TDV 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 or legally acceptable representative (LAR) signs and dates a written informed consent form (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.
5. The participant's parent or LAR agrees that a baseline blood sample may be taken from the participant.
Cases:
1. The participant is part of the cohort.
2. The participant is hospitalized and clinically diagnosed with dengue.
3. The participant has a blood sample available that was taken preferably within 5 days of fever onset and/or onset of symptoms compatible with dengue.
4. The participant tested positive for dengue by RT-PCR.
Controls:
1. The participant is part of the cohort.
2. The participant had not been hospitalized with VCD at any point between enrollment in the cohort and the index date (that is, when his/her matched case was hospitalized with CDD).
3. The participant is a resident in the same neighbourhood as the matched case.
4. The participant's date of birth is in the same calendar year as the matched case.
Exclusion Criteria
To be eligible for inclusion as a case participants must not meet any of the following criteria:
1. The participant has been vaccinated with TDV, a tetravalent, live attenuated, chimeric dengue vaccine in a yellow fever 17D backbone (CYD-TDV), or an investigational dengue vaccine prior to cohort enrollment.
2. Contraindications as per the locally approved label/product information leaflet.
Controls:
To be eligible for inclusion as a control participants must not meet any of the following criteria:
1. The participant has been vaccinated with TDV, CYD-TDV, or an investigational dengue vaccine prior to cohort enrollment.
2. Contraindications as per the locally approved label/product information leaflet.
3. The participant could not be contacted at the time of being selected as a control.
18 Years
ALL
Yes
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Pattaya Patamakhun Hospital
Bang Lamung, Changwat Chon Buri, Thailand
Nakhon Phanom hospital
Nakhon Phanom, Changwat Nakhon Phanom, Thailand
Phra Nakhon Si Ayutthaya Hospital
Mueang Phra Nakhon Si Ayutthaya, Phra Nakhon Si Ayutthaya, Thailand
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Related Links
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Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
Other Identifiers
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EUPAS1000000218
Identifier Type: REGISTRY
Identifier Source: secondary_id
DEN-401
Identifier Type: -
Identifier Source: org_study_id
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