Núcleo de Pesquisa Clínica do Rio Grande do Sul | Porto Alegre, Brazil
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About
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.
Enrollment
Sex
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Inclusion criteria
Male participants are eligible to participate if they agree to the following for at least 90 days after administration of study intervention:
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
Is dengue seronegative based on a pre-vaccination point of care (POC) dengue test.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
1,364 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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