Study type

Study type

Non-interventional study

Scope of the study

Safety study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(J07BX) Other viral vaccines
Population studied

Age groups

Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)

Estimated number of subjects

30000
Study design details

Main study objective

To evaluate the safety profile of Dengvaxia® when used in the real-world immunization setting.

Outcomes

Selected AEs (allergic reactions including anaphylactic, multi-organ failure, aseptic meningitis, Guillain-Barré syndrome, Fisher syndrome, acute disseminated encephalomyelitis, epilepsy, convulsions), during short-term period,6 months after each dose.Hospitalized dengue disease.Other SAEs during the short term surveillance, SAEs leading to hospitalization or death during the long term. Misuse of Dengvaxia® i.e. not in accordance with the authorized product information.

Data analysis plan

To quantify the incidence of the selected AEs, simple frequencies, incidence rates (with 95% confidence intervals), and time of occurrence will be obtainedIn order to assess the association between Dengvaxia® and each of the selected AEs for which a risk window can be defined after vaccination (primary objective for the short-term surveillance period), occurrence of three (3) cases or more will trigger a SCCS (Self-controlled case series) analysis using CEM data collected over the four and half (4.5) months following each vaccine dose/A sensitivity analysis will be conducted using all 6 months follow-up period for the SCCS instead of 4.5Lifetable analyses of time to event onset will be obtained in order to identify safety signals For hospitalized dengue, occurrence of three (3) or more confirmed cases will trigger a nested case-control analysis