Clinical Trial: Clinical Bridging Study Between V181 (Dengue Quadrivalent Vaccine rDENV?30 [Live, Attenuated]) to Butantan Dengue Vaccine (Butantan-DV) in Healthy Adults 18 to 50 Years of Age in Brazil (V181-002)
Study Status: COMPLETED
Recruit Status: COMPLETED
Condition: Dengue
Study Type: INTERVENTIONAL
Official Title: A Phase 2, Randomized, Double-Blind, Multicenter, Safety and Immunogenicity Clinical Bridging Study to Compare V181 (Dengue Quadrivalent Vaccine rDENV?30 [Live, Attenuated]) to Butantan Dengue Vaccine
Brief Summary:
The purpose of this study is 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 is 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.
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