A Study in Children and Teenagers to Learn if a TDV Dengue Vaccination Lowers the Chance of Hospital Stays for Dengue
ConditionDengue Fever
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-12
SponsorTakeda
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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 his/her enrollment into the study cohort.
The participant's parent(s) 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.
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.
Disqualifiers
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.
Contraindications as per the locally approved label/product information leaflet.
The participant has been vaccinated with TDV, CYD-TDV, or an investigational dengue vaccine prior to cohort enrollment.
Contraindications as per the locally approved label/product information leaflet.
Trial population
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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention
Other interventionThis is a non-interventional study.
Treatment groups
70,000 Participants
are divided into 1 treatment groupGroup A: Nested Case-control Participants1 intervention
Trial outcomes
Primary outcomes
1
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 36Secondary outcomes
1
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 362
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 363
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 Source ClinicalTrials.gov