This randomized, double-blind, three parallel-group, multicenter, phase 3b trial evaluates the safety and immunogenicity of Butantan-DV. The study compares two primary immunization regimens (Butantan-DV/Butantan-DV vs. Butantan-DV/Placebo) across both the 2-11 and 12-17 age cohorts. It also evaluates the manufacturing facility transition for the Butantan-DV dengue vaccine, by comparing the open-label arm WuXi Biologics (Butantan-DV group) to both double-blinded Butantan-DV/Butantan-DV and Butantan-DV/Placebo arms, in adolescents aged 12 to 17.
Inclusion Criteria:
Exclusion Criteria:
fernanda.boulos@fundacaobutantan.org.br
Participants and investigator in the double-blind step from two of the three parallel groups (assessment of primary immunization).
Butantan-DV manufactured at the Butantan Institute
Butantan-DV manufactured at the WuXi Biologics CRDMO
Placebo (0 PFU), solution of the simplified lyophilized formulation, manufactured at the Butantan Institute
erique.miranda@fundacaobutantan.org.br+551137237054
Phase II Trial to Evaluate Safety and Immunogenicity of a Dengue 1,2,3,4 (Attenuated) Vaccine
Phase III Trial to Evaluate Efficacy and Safety of a Tetravalent Dengue Vaccine
Butantan-DV Vaccine in Elderly Populations (DEN-04-IB)
Clinical Bridging Study Between V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [Live, Attenuated]) to Butantan Dengue Vaccine (Butantan - DV) in Healthy Adults 18 to 50 Years of Age in Brazil (V181 - 002)
Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) in Adolescents in Non-Endemic Area(s)
Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Participants
Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose
Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV)