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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)

Dengue Clinical Trial

Official title:
A Phase 2, Randomized, Double-Blind, Multicenter, Safety and Immunogenicity Clinical Bridging Study to Compare V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [Live, Attenuated]) to Butantan Dengue Vaccine (Butantan-DV) in Healthy Adults 18 to 50 Years of Age in Brazil

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05710224
Study type Interventional
Source Butantan Institute
Contact
Status Active, not recruiting
Phase Phase 2
Start date February 15, 2023
Completion date November 29, 2024
View Details
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