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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)

NCT05710224 PHASE2 COMPLETED Results posted

The purpose of this study was to demonstrate that V181 is safe and well tolerated and elicits an immune response that is non-inferior to that of Butantan - DV at Day 28 post-vaccination in adults 18 to 50 years of age in Brazil. The primary hypothesis was that V181 is non-inferior to Butantan - DV for each of the 4 dengue serotypes based on geometric mean titers (GMTs) and seroconversion rates at Day 28 post-vaccination.

Details

Lead sponsorButantan Institute
PhasePHASE2
StatusCOMPLETED
Enrolment1364
Start dateWed Feb 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionThu Dec 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

Brazil