DEN-401: The Association Between Prior Exposure to Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) and Dengue Hospitalization in a Pediatric and Adolescent Population: A Nested Case-Control Post-Authorization Effectiveness Study

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Other
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

  Other
• Non-interventional study design, other:
  Cohort with nested case-control effectiveness investigation

Study drug and medical condition

• Name of medicine:
  QDENGA
• Name of medicine, other:
  Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) ; ;
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BX04) dengue virus vaccines

  dengue virus vaccines
• Medical condition to be studied:
  Hospitalisation

Population studied

• Short description of the study 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.
• Age groups:
  Paediatric Population (< 18 years)
• Estimated number of subjects:
  70000

Study design details

• Study design:
  In this observational, nested case-control study, the vaccination status of cohort participants hospitalized for virologically confirmed dengue (VCD) (cases) will be compared with that of participants who are not hospitalized for VCD (controls).
• Main study objective:
  To estimate the association between completed vaccination with TDV (as part of a vaccination program) and hospitalization due to VCD, including severe dengue.
• Outcomes:
  The primary outcome will assess:; Association between completed vaccination with TDV (as part of a vaccination program) and hospitalization due to VCD, including severe dengue; ; The secondary outcome will assess:; The association between completed vaccination with TDV (as part of a vaccination program) and subsequent hospitalization due to VCD, including severe dengue, by:; • The infecting dengue serotype (DENV 1, DENV 2, DENV 3, and DENV 4).; • The baseline dengue serostatus (seronegative and seropositive at baseline).; • The infecting dengue serotype and the baseline dengue serostatus.
• Data analysis plan:
  Data analysis will be conducted using a conditional logistic regression model with log hazard rate ratio (HRR) as the output.