Hospitalization for clinically diagnosed dengue (CDD), with a confirmed positive RT- PCR result (virologically confirmed dengue [VCD]) Dengue, Dengue Virus, Dengue Vaccine, Nested case-control study
Conditions
Interventions
Fully vaccinated/completed vaccination (approved vaccination schedule): If he/she has received a 2-dose series of TDV according to national recommendations at least 30 days before developing fever and
Prevention,Prevention
Dengue vaccinated ,Dengue unvaccinated
Sponsors
Takeda Vaccines Inc
National Vaccine Institute of Thailand
Eligibility
Sex/Gender
All
Age
7 Years to 10 Years
Inclusion criteria
Inclusion criteria: Cohort 1 The participant is a child or adolescent eligible to be vaccinated with Qdenga 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(s) or LAR signs and dates a written 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(s) or LAR agrees that a baseline blood sample may be taken from the participant. Cases To be eligible for inclusion as a case, participants must meet the following inclusion criteria: 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 To be eligible for inclusion as a matched control, participants must meet the following inclusion criteria: 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 (ie, when his/her matched case was hospitalized with CDD). 3 The participant is a resident in the same neighborhood (village/subdistrict in Thailand) as the matched case. 4 The participants date of birth is in the same calendar year as the matched case.
Exclusion criteria
Exclusion criteria: - The participant is pregnant at the time of cohort enrollment. - The participant has been vaccinated with Qdenga, CYD-TDV, or an investigational dengue vaccine prior to cohort enrollment. - Contraindications as per the locally approved label/product information leaflet. - The participant could not be contacted at the time of being selected as a control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospitalization Due to VCD of Any Dengue Serotype in Unvaccinated and Fully Vaccinated Participants Up to 36 months Number of participants hospitalized due to VCD of any dengue serotype in unvaccinated and fully vaccinated participants | — |
Secondary
| Measure | Time frame |
|---|---|
| Hospitalization Due to VCD By Each Infecting Dengue Serotype (DENV-1, DENV-2, DENV 3, DENV-4) in Unvaccinated and Fully Vaccinated Participants Up to Month 36 Number of participants hospitalized due to VCD with each infecting dengue serotype (DENV 1, DENV-2, DENV-3, and DENV-4) in unvaccinated and fully vaccinated participants will be reported,Hospitalization Due to VCD by Baseline Dengue Serostatus (Seronegative and Seropositive) of Any Dengue Serotype in Unvaccinated and Fully Vaccinated Participants Up to Month 36 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.,Hospitalization Due to VCD By Each Infecting Dengue Serotype and Baseline Dengue Serostatus in Unvaccinated and Fully Vaccinated Participants Up to Month 36 Number of participants hospitalized due to VCD by each infecting dengue serotype and baseline dengue serostatus in unvaccinated and fully vaccinated participants will be reported. | — |
Countries
Thailand
Contacts
Public ContactDr. Chakrarat Pittayawonganon
Ministry of Public Health
Outcome results
None listed