Immunogenicity, Safety, and Efficacy of a Tetravalent Dengue Vaccine in Children and Adolescents: An Analysis by Age Group.

ABSTRACT:

Background

Dengue is an increasing threat to global health. This exploratory analysis evaluated the immunogenicity, safety, and vaccine efficacy (VE) of a live-attenuated tetravalent dengue vaccine (TAK-003) in participants enrolled in the phase 3 DEN-301 trial (NCT02747927), stratified by baseline age (4-5 years, 6-11 years, or 12-16 years).

Methods

Participants were randomized 2:1 to receive 2 doses of TAK-003, administered 3 months apart, or placebo. Dengue serostatus was evaluated at enrolment. VE against virologically confirmed dengue (VCD) and hospitalized VCD; immunogenicity (geometric mean titers [GMTs]); and safety were evaluated per age group through ∼4 years postvaccination.

Results

VE against VCD across serotypes was 43.5% (95% confidence interval [CI]: 25

SUBMITTER: Borja-Tabora C 

PROVIDER: S-EPMC11797386 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature